Job Description Description - External Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. The Sr. Manager, Clinical Development (Devices) will have global or regional responsibilities and fulfill the role of Clinical Scientist and/or Clinical Science Lead within the Integrated Evidence Strategy Team (IEST). The Sr. Manager, Clinical Development should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members. YOU ARE more than just a title, YOU ARE First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will 1. In collaboration with a Therapeutic Area Scientific Director (TA-SD), the Clinical Scientist and/or Clinical Science Lead will contribute to the design, conduct, analysis, and reporting of clinical trials. The Clinical Scientist and/or Clinical Science Lead will apply scientific training and clinical research experience to support all aspects of device and product development, from facilitating the transition from preclinical discovery to supporting the registration and commercialization of a product. The position supports the Global Development Lead and TA-SD through the following responsibilities: •Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of products in development. Attends congress and reviews literature to develop and augment expertise in therapeutic area •Help develop program strategy including the clinical development plan, Integrated evidence plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and help identify and evaluate business development opportunities. •Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR). •Participate in scientific education of internal and external stakeholders on the pre-clinical and clinical data relevant to program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations. •Contribute to the scientific content of Study Protocols, Investigator Brochures, IDFUs, Clinical Study Reports, Informed Consent Forms, and regulatory documents. •Contribute to creation of electronic database, investigator meetings, and associated training documents and review data completeness and fidelity throughout study conduct. • Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
03/28/2024
Full time
Job Description Description - External Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results. The Sr. Manager, Clinical Development (Devices) will have global or regional responsibilities and fulfill the role of Clinical Scientist and/or Clinical Science Lead within the Integrated Evidence Strategy Team (IEST). The Sr. Manager, Clinical Development should expect to be asked to participate in internal process improvement activities within R&D and Clinical Development, as well as mentor and provide guidance to junior team members. YOU ARE more than just a title, YOU ARE First class team player: collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership. You Will 1. In collaboration with a Therapeutic Area Scientific Director (TA-SD), the Clinical Scientist and/or Clinical Science Lead will contribute to the design, conduct, analysis, and reporting of clinical trials. The Clinical Scientist and/or Clinical Science Lead will apply scientific training and clinical research experience to support all aspects of device and product development, from facilitating the transition from preclinical discovery to supporting the registration and commercialization of a product. The position supports the Global Development Lead and TA-SD through the following responsibilities: •Contribute to the review, interpretation and communication of scientific data pertaining to the efficacy and safety of products in development. Attends congress and reviews literature to develop and augment expertise in therapeutic area •Help develop program strategy including the clinical development plan, Integrated evidence plan, product lifecycle plans, target product profiles and draft labels. Reviews competitive landscape and help identify and evaluate business development opportunities. •Responsible for providing focused scientific and clinical study support from start-up clinical study report (CSR). •Participate in scientific education of internal and external stakeholders on the pre-clinical and clinical data relevant to program. Engage opinion leader interactions to build pipeline awareness and foster research collaborations. •Contribute to the scientific content of Study Protocols, Investigator Brochures, IDFUs, Clinical Study Reports, Informed Consent Forms, and regulatory documents. •Contribute to creation of electronic database, investigator meetings, and associated training documents and review data completeness and fidelity throughout study conduct. • Collaborate cross-functionally to help create a scientific platform in support of the regulatory, commercial and medical education strategy for late-stage assets.
The Associate Marketing Manager, Global Brand Marketing will be working on the Barbie Global Brand Team, specifically focused on the Signature (collector-focused) business. Responsibilities • Working alongside the Senior Manager (Global Brand Marketing) and working closely with colleagues across the company, the Global Associate Marketing Manager will ensure all brand marketing projects are supported by business strategy, objectives and insights • Assist in gaining buy-in to global product strategies at all levels, as well as executional commitment from internal partners to activate across key markets and key lines of business • Work closely with the Product Design, Packaging and Development teams to bring innovative and compelling toys to market on time and on budget backed by Consumer Insights • Communicate regularly with regional teams and lines of business to ensure needs are being met • Present with confidence to drive brand strategy and products • Brief and develop marketing assets • Support management of product release calendar, asset reviews and messaging alignment for Signature business • Monitor key trends, brands and competitors' performance in all markets • Lead global business reporting and analysis • Act as point of contact for Signature segment inquiries and dissemination of information and assets Qualifications • 4+ years experience in marketing, preferably in product development and working with licensors • Thorough understanding of marketing mix and KPIs • Experience analyzing data and managing financials • Ability to synthesize data and pull insights to create recommendations • Strong skills presenting in front of large groups • Highly organized, independent and detail oriented with strong follow up skills • Strong time management, planning and project execution skills • Excellent written and verbal communication skills • Strong interpersonal skills with the ability to build solid collaborative relationships • Strong PowerPoint creation and presentation skills, proficiency in Outlook, Word and Excel
01/30/2022
Contractor
The Associate Marketing Manager, Global Brand Marketing will be working on the Barbie Global Brand Team, specifically focused on the Signature (collector-focused) business. Responsibilities • Working alongside the Senior Manager (Global Brand Marketing) and working closely with colleagues across the company, the Global Associate Marketing Manager will ensure all brand marketing projects are supported by business strategy, objectives and insights • Assist in gaining buy-in to global product strategies at all levels, as well as executional commitment from internal partners to activate across key markets and key lines of business • Work closely with the Product Design, Packaging and Development teams to bring innovative and compelling toys to market on time and on budget backed by Consumer Insights • Communicate regularly with regional teams and lines of business to ensure needs are being met • Present with confidence to drive brand strategy and products • Brief and develop marketing assets • Support management of product release calendar, asset reviews and messaging alignment for Signature business • Monitor key trends, brands and competitors' performance in all markets • Lead global business reporting and analysis • Act as point of contact for Signature segment inquiries and dissemination of information and assets Qualifications • 4+ years experience in marketing, preferably in product development and working with licensors • Thorough understanding of marketing mix and KPIs • Experience analyzing data and managing financials • Ability to synthesize data and pull insights to create recommendations • Strong skills presenting in front of large groups • Highly organized, independent and detail oriented with strong follow up skills • Strong time management, planning and project execution skills • Excellent written and verbal communication skills • Strong interpersonal skills with the ability to build solid collaborative relationships • Strong PowerPoint creation and presentation skills, proficiency in Outlook, Word and Excel
Job Description: The Compliance and Operational Risk (C&OR) Manager is responsible for engaging in activities to provide independent compliance and operational risk oversight of Front Line Unit or Control Function ("FLU/CF") performance and any related third party/vendor relationships in alignment with the Global Compliance - Enterprise Policy, the Operational Risk Management - Enterprise Policy (collectively "the Policies") and the Compliance and Operational Risk Management ("CORM") Program and Standard Operating Procedures (SOPs). As a member of an FLU or CF C&OR officer team, the C&OR Manager is accountable for proactive identification, management and escalation of compliance and operational risks through the execution of some or all of the below identified activities. This role exercises judgment and influence, and may constructively challenge FLU and CF leaders to support the CORM Program objectives, balancing business strategy with appropriate controls. The C&OR Manager proactively engages with other C&OR officers, including horizontal coverage owners and Enterprise Areas of Coverage ("EAC"), to provide comprehensive oversight of FLU/CF activities. This role develops and maintains a global coverage plan which defines the scope and risk-based focus of the second line's risk management activities. The C&OR Manager prepares materials for C&OR regulatory exams/audits/inquiries and may provide consultation to business leaders in preparation for FLU/CF regulatory exams/audits/inquiries. The C&OR Manager plans, drives and reviews team deliverables to support consistent quality of activities, processes and outputs. This role may contribute as a manager responsible for providing leadership direction to attract, assess, develop, motivate and retain a team, or may act as an individual contributor. The C&OR Manager contributes to the requirements of the CORM Program requirements including, but not limited to the following activities: • Produces and/or oversees the development of independent risk management reporting for respective area(s) of coverage as input governance and management routines • Provides subject matter expertise to assist the FLU/CF in establishing an annual learning plan, may be accountable for developing and delivering training content • Develops and maintains C&OR-owned policies and standards and/or provides oversight of FLU/CF-owned policies, standards and procedures to ensure regulatory and operational risk requirements are appropriately addressed, inclusive of conduct risk as applicable • Monitors the regulatory environment to identify regulatory changes applicable to area(s) of coverage, advises business leaders on those changes, directs the appropriate areas to implement or amend policies, standards, procedures and/or processes to address regulatory requirements, and challenges the implementation plan as needed; maintains a comprehensive regulatory inventory • Identifies, aggregates, reports, escalates, inspects and challenges remediation plans, and performs thematic analysis on FLU/CF-owned issues and control enhancements • Ensures C&OR "owned" issues and control enhancements are identified and addressed appropriately and timely • Contributes to or leads development of risk coverage plans, executes and / or oversees execution of independent risk monitoring, testing and risk assessments, communicates results • Reviews and challenges the FLU/CF process, risk, control (PRC) inventory and FLU/CF Risk & Control Self-Assessment (RCSA) • Reviews and challenges internal and external operational loss events, including development of remediation plans to strengthen controls, and approves where appropriate • Participates in Scenario Analysis activities for coverage areas and challenges as appropriate • Ensures metrics are designed to measure key risks and control performance, monitors and reports on metric performance and breach remediation Role responsibilities: -Globally coordinated risk oversight of electronic trading for flows across equities and fixed income. -Working with business heads & control partners to build uniform standards of electronic trading controls across various platforms so as to mitigate risk and subsequent regulatory impact and / or financial loss. -Identifying and categorizing the risks associated with electronically traded flow. -In coordination with the business, technology and control partners establish and/or validate that oversight exists for all identified risks. -Ensuring risk oversight feeds into the appropriate governance model. -Reviewing intraday trading limits structure/controls and establishing/validating limit setting logic where necessary. -Development of metrics and identification of key performance metrics quantifying the effectiveness of the risk framework. -Reviewing electronically traded flow in the context of system capacity constraints and the operational environment. -Reviewing the use of trading algorithms and direct electronic access execution paths and the associated risk & control framework. -Developing a uniform standard for the use of trading algorithm and DEA execution path controls taking account trading requirements and market impact. -Working with Technology to identify and manage control risks. -Contribute to test planning and deployment as appropriate. Additional role responsibilities: • Proactively engages other C&OR officers, Enterprise Areas of Coverage (EAC) roles, and horizontal function roles to provide comprehensive oversight of FLU and CF activities. • Conduct compliance and operational risk assessments of the Electronic Trading FLU, incorporating review of external loss events to assess control effectiveness. • Provides independent review and challenge of the FLU's Risk & Control Self-Assessment (RCSA). • Leads the efforts and/or contributes to monitoring and testing coverage plans and related metrics for the Electronic Trading FLU. • Monitor and test the effectiveness of the Electronic Trading FLU compliance and operational risk controls. • Identify aggregate, report and escalate compliance and operational risks, issues and control enhancements. • Executes and/or provides oversight of governance and management routines. • Identify compliance and operational risk training needs, provide subject matter expertise to support development of training curriculum, and inspect Electronic Trading FLU and third party participation. • Provides consultation to business leaders in preparations for regulatory exams and audits for Electronic Trading FLU. • Inspect that commitments made regarding actions in response to Matters Requiring Attention ("MRAs") and other actions are completed. • Escalate regulatory relations concerns to Compliance and Operational Risk Executive. Required Skills: • Bachelor's degree; • 5 - 8 years working in same arena or relevant risk management experience; • Knowledge of Equity and FICC products and market structure; • Understanding of trade processing systems, technology, and /or infrastructure; • Is able to independently lead projects and drive change with Senior Business and Risk Management teams; • Experience covering an Equities and / or FICC Electronic Trading business and has familiarity with the tools, services, marketing and other offerings of such business; • Quantitative and / or risk management skills / experience; • Has knowledge of laws, rules, and regulations applicable to order creation, routing, execution and post trade activities and the order management systems and platform infrastructures that support them; • Has experience with the process of the creation of and changes to algorithms working within an Electronic Trading infrastructure; • Has experience building or having input into to the creation of surveillance reports and testing models for use in the area of Electronic Trading order and execution flows; • Has first-hand experience in the area of risk assessment and policy creation across all aspects of Electronic Trading; • Has experience in building broad Risk and Compliance programs in the area of Electronic Trading. Job Band: H4 Shift: 1st shift (United States of America) Hours Per Week: 40 Weekly Schedule: Referral Bonus Amount: 0 --> Job Description: The Compliance and Operational Risk (C&OR) Manager is responsible for engaging in activities to provide independent compliance and operational risk oversight of Front Line Unit or Control Function ("FLU/CF") performance and any related third party/vendor relationships in alignment with the Global Compliance - Enterprise Policy, the Operational Risk Management - Enterprise Policy (collectively "the Policies") and the Compliance and Operational Risk Management ("CORM") Program and Standard Operating Procedures (SOPs). As a member of an FLU or CF C&OR officer team, the C&OR Manager is accountable for proactive identification, management and escalation of compliance and operational risks through the execution of some or all of the below identified activities. This role exercises judgment and influence, and may constructively challenge FLU and CF leaders to support the CORM Program objectives, balancing business strategy with appropriate controls. The C&OR Manager proactively engages with other C&OR officers, including horizontal coverage owners and Enterprise Areas of Coverage ("EAC"), to provide comprehensive oversight of FLU/CF activities. This role develops and maintains a global coverage plan which defines the scope and risk-based focus of the second line's risk management activities..... click apply for full job details
09/24/2021
Full time
Job Description: The Compliance and Operational Risk (C&OR) Manager is responsible for engaging in activities to provide independent compliance and operational risk oversight of Front Line Unit or Control Function ("FLU/CF") performance and any related third party/vendor relationships in alignment with the Global Compliance - Enterprise Policy, the Operational Risk Management - Enterprise Policy (collectively "the Policies") and the Compliance and Operational Risk Management ("CORM") Program and Standard Operating Procedures (SOPs). As a member of an FLU or CF C&OR officer team, the C&OR Manager is accountable for proactive identification, management and escalation of compliance and operational risks through the execution of some or all of the below identified activities. This role exercises judgment and influence, and may constructively challenge FLU and CF leaders to support the CORM Program objectives, balancing business strategy with appropriate controls. The C&OR Manager proactively engages with other C&OR officers, including horizontal coverage owners and Enterprise Areas of Coverage ("EAC"), to provide comprehensive oversight of FLU/CF activities. This role develops and maintains a global coverage plan which defines the scope and risk-based focus of the second line's risk management activities. The C&OR Manager prepares materials for C&OR regulatory exams/audits/inquiries and may provide consultation to business leaders in preparation for FLU/CF regulatory exams/audits/inquiries. The C&OR Manager plans, drives and reviews team deliverables to support consistent quality of activities, processes and outputs. This role may contribute as a manager responsible for providing leadership direction to attract, assess, develop, motivate and retain a team, or may act as an individual contributor. The C&OR Manager contributes to the requirements of the CORM Program requirements including, but not limited to the following activities: • Produces and/or oversees the development of independent risk management reporting for respective area(s) of coverage as input governance and management routines • Provides subject matter expertise to assist the FLU/CF in establishing an annual learning plan, may be accountable for developing and delivering training content • Develops and maintains C&OR-owned policies and standards and/or provides oversight of FLU/CF-owned policies, standards and procedures to ensure regulatory and operational risk requirements are appropriately addressed, inclusive of conduct risk as applicable • Monitors the regulatory environment to identify regulatory changes applicable to area(s) of coverage, advises business leaders on those changes, directs the appropriate areas to implement or amend policies, standards, procedures and/or processes to address regulatory requirements, and challenges the implementation plan as needed; maintains a comprehensive regulatory inventory • Identifies, aggregates, reports, escalates, inspects and challenges remediation plans, and performs thematic analysis on FLU/CF-owned issues and control enhancements • Ensures C&OR "owned" issues and control enhancements are identified and addressed appropriately and timely • Contributes to or leads development of risk coverage plans, executes and / or oversees execution of independent risk monitoring, testing and risk assessments, communicates results • Reviews and challenges the FLU/CF process, risk, control (PRC) inventory and FLU/CF Risk & Control Self-Assessment (RCSA) • Reviews and challenges internal and external operational loss events, including development of remediation plans to strengthen controls, and approves where appropriate • Participates in Scenario Analysis activities for coverage areas and challenges as appropriate • Ensures metrics are designed to measure key risks and control performance, monitors and reports on metric performance and breach remediation Role responsibilities: -Globally coordinated risk oversight of electronic trading for flows across equities and fixed income. -Working with business heads & control partners to build uniform standards of electronic trading controls across various platforms so as to mitigate risk and subsequent regulatory impact and / or financial loss. -Identifying and categorizing the risks associated with electronically traded flow. -In coordination with the business, technology and control partners establish and/or validate that oversight exists for all identified risks. -Ensuring risk oversight feeds into the appropriate governance model. -Reviewing intraday trading limits structure/controls and establishing/validating limit setting logic where necessary. -Development of metrics and identification of key performance metrics quantifying the effectiveness of the risk framework. -Reviewing electronically traded flow in the context of system capacity constraints and the operational environment. -Reviewing the use of trading algorithms and direct electronic access execution paths and the associated risk & control framework. -Developing a uniform standard for the use of trading algorithm and DEA execution path controls taking account trading requirements and market impact. -Working with Technology to identify and manage control risks. -Contribute to test planning and deployment as appropriate. Additional role responsibilities: • Proactively engages other C&OR officers, Enterprise Areas of Coverage (EAC) roles, and horizontal function roles to provide comprehensive oversight of FLU and CF activities. • Conduct compliance and operational risk assessments of the Electronic Trading FLU, incorporating review of external loss events to assess control effectiveness. • Provides independent review and challenge of the FLU's Risk & Control Self-Assessment (RCSA). • Leads the efforts and/or contributes to monitoring and testing coverage plans and related metrics for the Electronic Trading FLU. • Monitor and test the effectiveness of the Electronic Trading FLU compliance and operational risk controls. • Identify aggregate, report and escalate compliance and operational risks, issues and control enhancements. • Executes and/or provides oversight of governance and management routines. • Identify compliance and operational risk training needs, provide subject matter expertise to support development of training curriculum, and inspect Electronic Trading FLU and third party participation. • Provides consultation to business leaders in preparations for regulatory exams and audits for Electronic Trading FLU. • Inspect that commitments made regarding actions in response to Matters Requiring Attention ("MRAs") and other actions are completed. • Escalate regulatory relations concerns to Compliance and Operational Risk Executive. Required Skills: • Bachelor's degree; • 5 - 8 years working in same arena or relevant risk management experience; • Knowledge of Equity and FICC products and market structure; • Understanding of trade processing systems, technology, and /or infrastructure; • Is able to independently lead projects and drive change with Senior Business and Risk Management teams; • Experience covering an Equities and / or FICC Electronic Trading business and has familiarity with the tools, services, marketing and other offerings of such business; • Quantitative and / or risk management skills / experience; • Has knowledge of laws, rules, and regulations applicable to order creation, routing, execution and post trade activities and the order management systems and platform infrastructures that support them; • Has experience with the process of the creation of and changes to algorithms working within an Electronic Trading infrastructure; • Has experience building or having input into to the creation of surveillance reports and testing models for use in the area of Electronic Trading order and execution flows; • Has first-hand experience in the area of risk assessment and policy creation across all aspects of Electronic Trading; • Has experience in building broad Risk and Compliance programs in the area of Electronic Trading. Job Band: H4 Shift: 1st shift (United States of America) Hours Per Week: 40 Weekly Schedule: Referral Bonus Amount: 0 --> Job Description: The Compliance and Operational Risk (C&OR) Manager is responsible for engaging in activities to provide independent compliance and operational risk oversight of Front Line Unit or Control Function ("FLU/CF") performance and any related third party/vendor relationships in alignment with the Global Compliance - Enterprise Policy, the Operational Risk Management - Enterprise Policy (collectively "the Policies") and the Compliance and Operational Risk Management ("CORM") Program and Standard Operating Procedures (SOPs). As a member of an FLU or CF C&OR officer team, the C&OR Manager is accountable for proactive identification, management and escalation of compliance and operational risks through the execution of some or all of the below identified activities. This role exercises judgment and influence, and may constructively challenge FLU and CF leaders to support the CORM Program objectives, balancing business strategy with appropriate controls. The C&OR Manager proactively engages with other C&OR officers, including horizontal coverage owners and Enterprise Areas of Coverage ("EAC"), to provide comprehensive oversight of FLU/CF activities. This role develops and maintains a global coverage plan which defines the scope and risk-based focus of the second line's risk management activities..... click apply for full job details
Summary We are currently seeking a Senior Manager, Regulatory Affairs experienced in regulatory affairs. The incumbent is responsible for supporting regulatory strategy and planning activities associated with assigned programs. Activities include managing submissions, managing, and coordinating engagements with Health Authorities, managing responses to health authority queries, and liaising with CROs. Efficiency and effectiveness in delivering the work products are critical to success in the job. The position will report to the program-specific Global Regulatory Lead. Responsibilities Develop and implement tactics to facilitate the creation, review and approval of regulatory documents supporting clinical development activities leading to marketing application submission, review and approval Coordinate and facilitate planning and execution of team engagements with health authorities, including meetings and all correspondence Review technical reports and summary documents for submission to FDA and global health authorities (e.g., clinical protocols and study reports; investigator brochures, pharmacology & toxicology reports, DSURs) for adherence to regulatory guidelines, strategies, and commitments Coordinate and administer work processes within the company's electronic document management system (EDMS) that lead to approval of documentation intended for regulatory submission Coordinate with contract research organizations (CROs) to ensure provision of documents supporting clinical trials and submission activities in countries outside the US Familiarity with the interpretation of applicable FDA, Canadian, EU, PMDA and ICH guidelines related to clinical trial and marketing applications Provide and manage tactical regulatory plans supporting program team goals Lead, manage, and coordinate the content development process (planning, creation, review and approval) of selected regulatory documentation for inclusion in submissions to health authorities Provide advice to authors on the interpretation of templates (including internal and external regulatory guidelines) and the content of modules Draft regulatory documentation from approved sources. Review regulatory documentation for consistency and compliance with guidelines Prepare data for inclusion in regulatory submissions supporting development activities, including NDAs, INDs, IMPDs, QOSs (Canada), CTAs and DSURs Author and review forms supporting information in INDs and CTAs Coordinate responses to questions from health authorities Other duties as assigned or required Qualifications BS or higher level degree in a science-related discipline Minimum of 8 years' experience in a regulatory function in the pharmaceutical/biotechnology industry Experience in producing development (IND/CTA) and marketing applications (NDA/MAA) in eCTD format for global health authority submissions Knowledge of product development activities, including non-clinical studies, clinical trials, and manufacturing NDA/MAA preparation and/or commercialization experience preferred Strong leadership, organization, and prioritization skills Excellent analytical and project planning skills Exceptional written and verbal communication skills Proven ability to manage in a matrix environment and to work collaboratively across all levels of the organization Working knowledge of an EDMS Highly proficient in Word, Excel, PowerPoint, Microsoft Project, and SharePoint; experience with Smartsheet is helpful Travel up to 10% (when COVID restrictions are lifted)
03/10/2021
Full time
Summary We are currently seeking a Senior Manager, Regulatory Affairs experienced in regulatory affairs. The incumbent is responsible for supporting regulatory strategy and planning activities associated with assigned programs. Activities include managing submissions, managing, and coordinating engagements with Health Authorities, managing responses to health authority queries, and liaising with CROs. Efficiency and effectiveness in delivering the work products are critical to success in the job. The position will report to the program-specific Global Regulatory Lead. Responsibilities Develop and implement tactics to facilitate the creation, review and approval of regulatory documents supporting clinical development activities leading to marketing application submission, review and approval Coordinate and facilitate planning and execution of team engagements with health authorities, including meetings and all correspondence Review technical reports and summary documents for submission to FDA and global health authorities (e.g., clinical protocols and study reports; investigator brochures, pharmacology & toxicology reports, DSURs) for adherence to regulatory guidelines, strategies, and commitments Coordinate and administer work processes within the company's electronic document management system (EDMS) that lead to approval of documentation intended for regulatory submission Coordinate with contract research organizations (CROs) to ensure provision of documents supporting clinical trials and submission activities in countries outside the US Familiarity with the interpretation of applicable FDA, Canadian, EU, PMDA and ICH guidelines related to clinical trial and marketing applications Provide and manage tactical regulatory plans supporting program team goals Lead, manage, and coordinate the content development process (planning, creation, review and approval) of selected regulatory documentation for inclusion in submissions to health authorities Provide advice to authors on the interpretation of templates (including internal and external regulatory guidelines) and the content of modules Draft regulatory documentation from approved sources. Review regulatory documentation for consistency and compliance with guidelines Prepare data for inclusion in regulatory submissions supporting development activities, including NDAs, INDs, IMPDs, QOSs (Canada), CTAs and DSURs Author and review forms supporting information in INDs and CTAs Coordinate responses to questions from health authorities Other duties as assigned or required Qualifications BS or higher level degree in a science-related discipline Minimum of 8 years' experience in a regulatory function in the pharmaceutical/biotechnology industry Experience in producing development (IND/CTA) and marketing applications (NDA/MAA) in eCTD format for global health authority submissions Knowledge of product development activities, including non-clinical studies, clinical trials, and manufacturing NDA/MAA preparation and/or commercialization experience preferred Strong leadership, organization, and prioritization skills Excellent analytical and project planning skills Exceptional written and verbal communication skills Proven ability to manage in a matrix environment and to work collaboratively across all levels of the organization Working knowledge of an EDMS Highly proficient in Word, Excel, PowerPoint, Microsoft Project, and SharePoint; experience with Smartsheet is helpful Travel up to 10% (when COVID restrictions are lifted)
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/26/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/26/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/25/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/25/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/25/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/25/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/25/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/25/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/25/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
01/25/2021
Full time
A career within Regulatory Risk and Compliance services, will provide you with the opportunity to help companies rethink their approach to risk and create a sustainable risk advantage. We?re a part of a unique client proposition, assisting our clients develop proper internal controls by leveraging analytics and technology solutions to underpin efficient execution of governance, to optimise their risk and compliance policies and processes, and improve business performance. To really stand out and make us fit for the future in a constantly changing world, each and every one of us at PwC needs to be an authentic and inclusive leader, at all grades/levels and in all lines of service. To help us achieve this we have the PwC Professional; our global leadership development framework. It gives us a single set of expectations across our lines, geographies and career paths, and provides transparency on the skills we need as individuals to be successful and progress in our careers, now and in the future. As a Manager, you'll work as part of a team of problem solvers, helping to solve complex business issues from strategy to execution. PwC Professional skills and responsibilities for this management level include but are not limited to: Pursue opportunities to develop existing and new skills outside of comfort zone. Act to resolve issues which prevent effective team working, even during times of change and uncertainty. Coach others and encourage them to take ownership of their development. Analyse complex ideas or proposals and build a range of meaningful recommendations. Use multiple sources of information including broader stakeholder views to develop solutions and recommendations. Address sub-standard work or work that does not meet firm's/client's expectations. Develop a perspective on key global trends, including globalisation, and how they impact the firm and our clients. Manage a variety of viewpoints to build consensus and create positive outcomes for all parties. Focus on building trusted relationships. Uphold the firm's code of ethics and business conduct. Our Regulatory Affairs consultants help clients understand and address regulatory challenges at critical stages of product development, commercialization and distribution. This high performing team advises clients globally on the management and performance of their product portfolios and overall business with a focus in regulatory strategy and process improvement, regulatory project management, operational support for various regulatory functions, and regulatory planning and due-diligence in connection with M&A and industry new entrants. _________________________________________________________________________________________ Minimum Year(s) of Experience: 5+ years of Client Facing Advisory Consulting experience is preferred, but open to PLS Risk & Regulatory experience in Industry. Minimum Degree Required: Bachelor's degree Degree Preferred: Advanced degree ie Juris Doctor, Masters of Business Administration, Masters of Public Health, Masters in Regulatory Affairs, RAPS Certification (RAC). Knowledge Preferred: 1. Demonstrates proven thorough knowledge of, and success performing on, regulatory projects in more than one of the following areas a. Ensuring adherence to pharmaceutical and medical device product development, approval and registration requirements/processes both US and globally including, but not limited to Coordinating/preparing regulatory submissions (eg, implementing submission templates, overseeing quality control of regulatory documents and submissions etc.) and product registration packages for local regulatory agencies Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process. Ensuring timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations Investigating regulatory history of similar products to assess approval or registration implications b. Working in partnership with the local teams to identify key regulatory requirements for projects and business initiatives c. Assisting with preparation of routine reports and regulatory agency communications d. Assisting with building, updating and maintaining paper/electronic regulatory document archival systems e. Assisting with review of promotional/advertising or educational items 2. Demonstrates proven thorough functional and industry knowledge associated with US and global regulatory agency history, guidelines, policies, standards, practices, requirements and precedents (eg, principles and requirements of applicable global product laws, submission/registration types and requirements GxPs (ie, GCPs, GMPs), principles and requirements of promotion, advertising and labeling etc.). Skills Preferred: Communicates with clients in an organized and knowledgeable manner, delivering clear requests for information, demonstrating flexibility in prioritizing and completing tasks and communicating potential conflicts to a supervisor. Demonstrates proven abilities and success in identifying and addressing clients? or managers? needs, including actively participating in client or management discussions and meetings, and preparing concise, accurate project documents. Participates in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry white paper, and attendance at industry conference. All qualified applicants will receive consideration for employment at PwC without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. PwC is proud to be an affirmative action and equal opportunity employer.
Broking Underwriting Support What can you expect? The Broking Underwriting Support colleague is responsible for coordinating all placement support activities of the account while personally contributing to the creation, review and assessment of data, related exhibits, and light analysis. Provides support to all account team members onsite and/or remotely on assigned accounts. This role prompts and monitors key activities and tasks throughout the reinsurance placement in order to promote complete and timely compliance with quality and regulatory- driven processes and procedures in accordance with published guidelines. Liaise with others internally to facilitate efficient and effective pre-placement, placement and post-placement activities and services to Brokers and Clients. If applying your quantitative, compliance and relationship-building talents to the fast-paced and quality-driven environment offered by a premier, global risk consulting organization fits your professional goals, this job may be for you. What is in it for you? Being part of the Marsh & McLennan businesses; a premier global brand with the financial power to match Culture where continuous personal development brings opportunity for professional growth and mobility Competitive pay, full benefits package - starting day one (medical, dental, vision, STD/LTD, life insurance, generous 401k match AND automatic contribution Generous paid time off for vacation, sick, company holidays and time to give back to your community Employee Resource Groups, which provide access to leaders, relevant volunteer and mentoring opportunities and interactions with counterparts in industry groups and client organizations Working with the most innovative and respected reinsurance colleagues in the industry We will count on you to: Review client data submitted during the placement/renewal process and update annual renewal exhibits as requested, offering relevant analysis of trends and potential data issues. Learn our systems - Set up / renew program, create submission, select approved markets, send submissions, download quotes, send FOTs, download authorizations/declinations, send signed lines, finalize in GCMP making sure all information is accurately reflected. Track placement status of assigned accounts. Follow-up with broker for updates and information as necessary. Communicate with client and/or markets during the placement process as requested. Using Company templates and disclaimers, when applicable, draft and secure broker sign off of the initial request for renewal information, marketing list, placement process updates, final binding of the reinsurance program and post- placement client books/communications, as requested. Provide the broker with assistance including researching financial statements, product lines, geographic exposures, and current reinsurance program information using available resources as required. Interface with other Departments to provide client data to be used for modeling, research claim or premium issues and facilitate contract wording negotiation flow as necessary. Review, package and transmit contract documents to Reinsurers according to procedure, upon instructions from Contract Analyst/Associate. Assist Contract drafters by having primary responsibility for obtaining properly signed contract documents from reinsurers and aggressively pursuing by phone, e-mail, letter, etc., until all executed documents have been received. Escalate in accordance with procedure and input contract status data on the document tracking system as required. Provide status reports according to procedure and upon request. Scan/upload and name all contract documents as received from reinsurers, Clients and/or Analysts/Associates and transmit completed signatures. Utilize Contracts Dashboard and/other legacy tracking tools to manage contract performance. Assist with scheduling of reinsurer audits and visits with client, attending if requested. Business Knowledge Maintain broad understanding of the environment in which the client operates and the marketplace in which the transactions that Guy Carpenter handles take place. Using the Market Reference Guide, develop an understanding of the differences between the reinsurer who bears the risk on the contract versus the parent or group entity to ensure proper legal reinsurer name is entered in systems and correct financials and NAIC codes are accurately communicated to clients. Participate in team meetings and activities to share opinions, ideas, knowledge and solutions; maintain strong working relationships and participate in initiatives and/or contribute where required to deliver outcomes. Seek opportunities to increase own understanding and improve the services provided. Compliance and Regulatory Review Ensure all records/forms for assigned accounts are properly completed and stored in accordance with policy. Understand all best practice procedures and compliance policies. When new procedures are provided, understand and adopt new procedures as rolled out, take required training and speak up with any question or concerns uncovered in your role at Guy Carpenter. Follow all best practice procedures and compliance requirements, including but not limited to building a complete placement file as the placement progresses to minimize errors & omissions. Client Services Provide client and broker with comprehensive meeting book for marketing trips and convention attendance. Respond to client requests for information (reinsurer, financial reports, industry issues, etc.), as directed by senior broker, coordinating with Market Information and other departments as necessary, and clearing with senior broker. Other Attend visiting client and reinsurer meetings, as necessary What you need to have: Associate's Degree 3-5 years in a corporate environment strongly preferred; related experience in data review, scrubbing and comparative analysis a plus, as is exposure to the insurance/reinsurance industry. Mastery of Microsoft Excel (including formulas, charts and graphs) Good PowerPoint skills Proven success in performing light analysis in a business strategy context, preferably in a reinsurance, insurance or investment environment. Ability to analyze results and draw relevant general observations/conclusions Knowledge, or ability to quickly acquire knowledge, of basic insurance/reinsurance concepts and terms. Strong interpersonal skills for establishing and maintaining good internal relationships and interactions with clients and reinsurers. Strong verbal and writing skills for internal and external communications with clients, reinsurers, Guy Carpenter colleagues at various levels. Strong ability to prioritize workload according to volume, urgency, etc. Strong organizational skills and the ability to pay attention to detail and multi-task. Good problem-solving skills to identify and anticipate problems and to begin to formulate resolutions and recognize when to escalate to manager. What makes you stand out: Bachelor's Degree and applicable or transferrable experience preferred. CPCU, CLU or ARe designation. Will be encouraged to complete the Associate in Reinsurance (ARe) designation in this role. Procedural compliance orientation and/or prior roles with light analytics a plus. High sense of personal accountability, focus on accuracy and details. Personable and likely to become a trusted resource within your broking teams Guy Carpenter & Company, LLC is a leading global risk and reinsurance specialist with more than 3,100 professionals in over 60 offices around the world. Guy Carpenter delivers a powerful combination of broking expertise, trusted strategic advisory services and industry-leading analytics to help clients adapt to emerging opportunities and achieve profitable growth. Guy Carpenter is a business of Marsh & McLennan Companies (NYSE: MMC), the world's leading professional services firm in the areas of risk, strategy and people. The company's 75,000 colleagues advise clients in over 130 countries. With annualized revenue approaching $17 billion, Marsh & McLennan helps clients navigate an increasingly dynamic and complex environment through four market-leading companies including Marsh , Mercer and Oliver Wyman . For more information, visit and follow Guy Carpenter on LinkedIn and Twitter Marsh & McLennan Companies and its Affiliates are EOE Minority/Female/Disability/Vet/Sexual Orientation/Gender Identity employers. #LI-AV3
01/16/2021
Full time
Broking Underwriting Support What can you expect? The Broking Underwriting Support colleague is responsible for coordinating all placement support activities of the account while personally contributing to the creation, review and assessment of data, related exhibits, and light analysis. Provides support to all account team members onsite and/or remotely on assigned accounts. This role prompts and monitors key activities and tasks throughout the reinsurance placement in order to promote complete and timely compliance with quality and regulatory- driven processes and procedures in accordance with published guidelines. Liaise with others internally to facilitate efficient and effective pre-placement, placement and post-placement activities and services to Brokers and Clients. If applying your quantitative, compliance and relationship-building talents to the fast-paced and quality-driven environment offered by a premier, global risk consulting organization fits your professional goals, this job may be for you. What is in it for you? Being part of the Marsh & McLennan businesses; a premier global brand with the financial power to match Culture where continuous personal development brings opportunity for professional growth and mobility Competitive pay, full benefits package - starting day one (medical, dental, vision, STD/LTD, life insurance, generous 401k match AND automatic contribution Generous paid time off for vacation, sick, company holidays and time to give back to your community Employee Resource Groups, which provide access to leaders, relevant volunteer and mentoring opportunities and interactions with counterparts in industry groups and client organizations Working with the most innovative and respected reinsurance colleagues in the industry We will count on you to: Review client data submitted during the placement/renewal process and update annual renewal exhibits as requested, offering relevant analysis of trends and potential data issues. Learn our systems - Set up / renew program, create submission, select approved markets, send submissions, download quotes, send FOTs, download authorizations/declinations, send signed lines, finalize in GCMP making sure all information is accurately reflected. Track placement status of assigned accounts. Follow-up with broker for updates and information as necessary. Communicate with client and/or markets during the placement process as requested. Using Company templates and disclaimers, when applicable, draft and secure broker sign off of the initial request for renewal information, marketing list, placement process updates, final binding of the reinsurance program and post- placement client books/communications, as requested. Provide the broker with assistance including researching financial statements, product lines, geographic exposures, and current reinsurance program information using available resources as required. Interface with other Departments to provide client data to be used for modeling, research claim or premium issues and facilitate contract wording negotiation flow as necessary. Review, package and transmit contract documents to Reinsurers according to procedure, upon instructions from Contract Analyst/Associate. Assist Contract drafters by having primary responsibility for obtaining properly signed contract documents from reinsurers and aggressively pursuing by phone, e-mail, letter, etc., until all executed documents have been received. Escalate in accordance with procedure and input contract status data on the document tracking system as required. Provide status reports according to procedure and upon request. Scan/upload and name all contract documents as received from reinsurers, Clients and/or Analysts/Associates and transmit completed signatures. Utilize Contracts Dashboard and/other legacy tracking tools to manage contract performance. Assist with scheduling of reinsurer audits and visits with client, attending if requested. Business Knowledge Maintain broad understanding of the environment in which the client operates and the marketplace in which the transactions that Guy Carpenter handles take place. Using the Market Reference Guide, develop an understanding of the differences between the reinsurer who bears the risk on the contract versus the parent or group entity to ensure proper legal reinsurer name is entered in systems and correct financials and NAIC codes are accurately communicated to clients. Participate in team meetings and activities to share opinions, ideas, knowledge and solutions; maintain strong working relationships and participate in initiatives and/or contribute where required to deliver outcomes. Seek opportunities to increase own understanding and improve the services provided. Compliance and Regulatory Review Ensure all records/forms for assigned accounts are properly completed and stored in accordance with policy. Understand all best practice procedures and compliance policies. When new procedures are provided, understand and adopt new procedures as rolled out, take required training and speak up with any question or concerns uncovered in your role at Guy Carpenter. Follow all best practice procedures and compliance requirements, including but not limited to building a complete placement file as the placement progresses to minimize errors & omissions. Client Services Provide client and broker with comprehensive meeting book for marketing trips and convention attendance. Respond to client requests for information (reinsurer, financial reports, industry issues, etc.), as directed by senior broker, coordinating with Market Information and other departments as necessary, and clearing with senior broker. Other Attend visiting client and reinsurer meetings, as necessary What you need to have: Associate's Degree 3-5 years in a corporate environment strongly preferred; related experience in data review, scrubbing and comparative analysis a plus, as is exposure to the insurance/reinsurance industry. Mastery of Microsoft Excel (including formulas, charts and graphs) Good PowerPoint skills Proven success in performing light analysis in a business strategy context, preferably in a reinsurance, insurance or investment environment. Ability to analyze results and draw relevant general observations/conclusions Knowledge, or ability to quickly acquire knowledge, of basic insurance/reinsurance concepts and terms. Strong interpersonal skills for establishing and maintaining good internal relationships and interactions with clients and reinsurers. Strong verbal and writing skills for internal and external communications with clients, reinsurers, Guy Carpenter colleagues at various levels. Strong ability to prioritize workload according to volume, urgency, etc. Strong organizational skills and the ability to pay attention to detail and multi-task. Good problem-solving skills to identify and anticipate problems and to begin to formulate resolutions and recognize when to escalate to manager. What makes you stand out: Bachelor's Degree and applicable or transferrable experience preferred. CPCU, CLU or ARe designation. Will be encouraged to complete the Associate in Reinsurance (ARe) designation in this role. Procedural compliance orientation and/or prior roles with light analytics a plus. High sense of personal accountability, focus on accuracy and details. Personable and likely to become a trusted resource within your broking teams Guy Carpenter & Company, LLC is a leading global risk and reinsurance specialist with more than 3,100 professionals in over 60 offices around the world. Guy Carpenter delivers a powerful combination of broking expertise, trusted strategic advisory services and industry-leading analytics to help clients adapt to emerging opportunities and achieve profitable growth. Guy Carpenter is a business of Marsh & McLennan Companies (NYSE: MMC), the world's leading professional services firm in the areas of risk, strategy and people. The company's 75,000 colleagues advise clients in over 130 countries. With annualized revenue approaching $17 billion, Marsh & McLennan helps clients navigate an increasingly dynamic and complex environment through four market-leading companies including Marsh , Mercer and Oliver Wyman . For more information, visit and follow Guy Carpenter on LinkedIn and Twitter Marsh & McLennan Companies and its Affiliates are EOE Minority/Female/Disability/Vet/Sexual Orientation/Gender Identity employers. #LI-AV3