Job Description The Medical Affairs Operations Manager will be responsible for direct operational and logistics support of Sobi Inc.'s key brands from a Medical Affairs perspective and will be embedded within the Brand-Medical-Team (BMT) operating model. Additionally, the successful candidate will lead both short and longer-term departmental projects in alignment with key business and team initiatives. This role will help drive execution of key tactics and deliverables while providing project management and logistics support (budgeting, analytics/metric reporting, medical materials creation/submission, etc.) for cross-functional activities and programs as well, which require a high-level of collaboration within the Sobi organization, in the Waltham office and globally, as well as with external vendors. Key Responsibilities: Lead, contribute to, and track process on brand and above-brand programs to ensure strategic focus and timely execution of deliverables. This includes coordination of interna and external timelines and deliverables, leadership of team efforts and progress monitoring, and collaborating cross-functionally within the Sobi organization to ensure seamless execution of various Medical Brand Plans. Provide operational efficiencies by implementing process improvements, providing guidance and support to team members, quickly identifying resolutions to issues, and developing communication plans to engage key stakeholders and increase program-related communication across the organization. This role also will act as a resource for strategy/plan related inquiries and will provide insights that will aid decision-making. Optimize achievement of overarching program strategy, including identifying process improvements, instituting best practices, supporting development of tools, templates and reports, and implementing feedback from team members. Management of team sites and project tracking tools to maximize communication updates and ensure content maintenance in-line with industry best practices; assess user feedback on an ongoing basis to prioritize future enhancements and improvement areas. Provide medical conference logistics including compliance submissions, booth registrations/logistics, medical materials delivery, and Handle assigned medical education grant proposals from intake through compliance submission and contracting. Deliver advisory board support from venue logistics through compliance documentation and HCP contracting/payment. Contribute to RWE programs including, but not limited to, planning, contracting, technical execution, and study reports (abstracts, posters, manuscripts). Project management of specific medical plan deliverables, including coordinating strategy/scope development, logistics and vendor management, and coordinating logistics and content development for events and trainings, as applicable. Provide contract support with external vendors which may include defining project scope, negotiation, and execution. Lead the planning and execution of ad hoc projects by ensuring that projects are aligned with U.S. objectives, supported by executive leadership, and have timely completion. Contribute to the development of processes and tools that continuously improve resource utilization and quality of clinical study activities and deliverables. Contribute to general operational MA activities including but not limited to budget management, vendor oversight, external meeting coordination, Medical Information and Pharmacovigilance operational activities, Metrics tracking and reporting, contracts, software implementation, and product launch/integration related activities.
03/23/2024
Full time
Job Description The Medical Affairs Operations Manager will be responsible for direct operational and logistics support of Sobi Inc.'s key brands from a Medical Affairs perspective and will be embedded within the Brand-Medical-Team (BMT) operating model. Additionally, the successful candidate will lead both short and longer-term departmental projects in alignment with key business and team initiatives. This role will help drive execution of key tactics and deliverables while providing project management and logistics support (budgeting, analytics/metric reporting, medical materials creation/submission, etc.) for cross-functional activities and programs as well, which require a high-level of collaboration within the Sobi organization, in the Waltham office and globally, as well as with external vendors. Key Responsibilities: Lead, contribute to, and track process on brand and above-brand programs to ensure strategic focus and timely execution of deliverables. This includes coordination of interna and external timelines and deliverables, leadership of team efforts and progress monitoring, and collaborating cross-functionally within the Sobi organization to ensure seamless execution of various Medical Brand Plans. Provide operational efficiencies by implementing process improvements, providing guidance and support to team members, quickly identifying resolutions to issues, and developing communication plans to engage key stakeholders and increase program-related communication across the organization. This role also will act as a resource for strategy/plan related inquiries and will provide insights that will aid decision-making. Optimize achievement of overarching program strategy, including identifying process improvements, instituting best practices, supporting development of tools, templates and reports, and implementing feedback from team members. Management of team sites and project tracking tools to maximize communication updates and ensure content maintenance in-line with industry best practices; assess user feedback on an ongoing basis to prioritize future enhancements and improvement areas. Provide medical conference logistics including compliance submissions, booth registrations/logistics, medical materials delivery, and Handle assigned medical education grant proposals from intake through compliance submission and contracting. Deliver advisory board support from venue logistics through compliance documentation and HCP contracting/payment. Contribute to RWE programs including, but not limited to, planning, contracting, technical execution, and study reports (abstracts, posters, manuscripts). Project management of specific medical plan deliverables, including coordinating strategy/scope development, logistics and vendor management, and coordinating logistics and content development for events and trainings, as applicable. Provide contract support with external vendors which may include defining project scope, negotiation, and execution. Lead the planning and execution of ad hoc projects by ensuring that projects are aligned with U.S. objectives, supported by executive leadership, and have timely completion. Contribute to the development of processes and tools that continuously improve resource utilization and quality of clinical study activities and deliverables. Contribute to general operational MA activities including but not limited to budget management, vendor oversight, external meeting coordination, Medical Information and Pharmacovigilance operational activities, Metrics tracking and reporting, contracts, software implementation, and product launch/integration related activities.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. The PV Alliance Management (PVAM) Specialist plays a key role in the PVAM Team, facilitating across functional teams, building relationships, and supporting the delivery of high quality PV Agreements to ensure timely and accurate collection, safety review, processing and reporting of adverse event data in compliance with applicable global regulations and Jazz Pharmaceuticals standard operating procedures and guidelines. To this end, the PVAM Specialist guides and facilitates effective working relationships within R&D Global Pharmacovigilance and Labeling, and cross-functionally with strategic departments within the company and its affiliates/subsidiaries to foster smooth, accurate, and timely flow of activities related to PV Agreements (PVA)s as well as effective contractual relationships with PV Service Providers. The PVAM Specialist is versed on PVAs, Safety Reporting Plans (SRPs), PV Service Provider Agreements, and acts as key contact person for internal and external customers, managing these alliances directly and working with the PVAM Team as well as in partnership with cross-functional staff. Working with the PVAM Manager, the Specialist may negotiate and maintain Agreements, including maintenance and reporting of KPIs/SLAs and participate in vendor governance. The Specialist will be responsible for coordinating PV activities related to Global Expansion in Canada and US. The PVAM Specialist may assist in special projects as assigned by the Pharmacovigilance (PV) department management. The PVAM Specialists have a breadth of responsibilities which are prioritized within the PVAM Team, and may be assigned to: Business Development & Opportunities Global PV Vendor Services Regional PV Vendor Services PVAM Specialist responsibilities may include PV alliance activities such as, but not limited to: Serve as the liaison between Global Pharmacovigilance and cross functional organizations, acting as a Pharmacovigilance ambassador and domain expert as well as increasing awareness within Global Pharmacovigilance of cross-functional customer/stakeholder needs and dependencies, including PV Service providers. Support implementation for new partnerships and maintenance/change Support establishment and maintenance of PVAs/SRPs/SPOPs/WOs associated with new business initiatives and opportunities. Interact with business process owners for additional information to address questions in establishing a PVA/SRP/SPOP/WO. Coordinate the PVA/SRP review by the safety review team, summarize agreement comments, and participate in the negotiation of the agreement. Contribute to resolving conflicts at team level or higher and facilitate decision making within the team. Escalate issues utilizing governance models and standard communication plans. Coordinate implementation of Safety Reporting plans for programs with the potential to generate safety information. Coordinate PV activities associated with in/out-licensing and marketing authorizations/withdrawals in Canada and United States. Collaborate with the cross-functional groups that have responsibility for activities that may generate adverse events or safety information such as (not limited to) Business Alliance/Development, Commercial, Medical Affairs. Support collection of information required to update designated sections of the PSMF. Organize and moderate meetings and author minutes/discussion summaries. Solicit items for and set agendas. Send out draft minutes/summaries for comments to both internal Global Pharmacovigilance and external PV Service Providers, and distribute final summaries to all participants, as well as senior PVAM staff. Follow up with meeting participants on the resolution of action items from meetings. Maintain and organize internal PVAM files (Agreements, supporting documents, meeting minutes). Participate in maintaining PVAM Jazz Portal and Mailbox. Conduct ad hoc/special projects and analyses for PVAM management. PVAM Specialist Essential Functions Adheres to company templates and GxP guidelines for documentation and communications Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training Other duties as required to support PVAM team Participate in the development and maintenance of PVAM activity workflow processes, department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced May serve as an individual contributor or a project manager for functional projects or workflows. May mentor other team members Participation in Inspections and Audits as identified, as well as active role in maintaining a business as usual inspection ready state of operating Takes responsibility for personal development and continuous improvement including keeping up to date with pharmacovigilance practices, legislation and guidelines. Work collaboratively with cross-functional teams to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes Collaborate effectively with Quality Assurance, Legal, and Project Management. Minimum Requirements BS/BA degree in health related or biological science related field 3 plus years of pharmaceutical drug safety/pharmacovigilance operations experience In depth knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS. Experience interacting with service providers or external business partners Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships Excellent oral and written communication skills, demonstrating professional maturity, confidence and competence Ability to work effectively within a matrix organization to achieve desired outcomes Track record of effective decision-making; makes good business decisions and analyses problems from multiple perspectives Ability to work across cultures, including in a virtual environment Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook) Team Building, Motivating and Influencing Others without authority Promoting Innovation and Process Improvement Maintaining activities Negotiation skills Strong analytical skills Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
09/11/2021
Full time
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and on Twitter. The PV Alliance Management (PVAM) Specialist plays a key role in the PVAM Team, facilitating across functional teams, building relationships, and supporting the delivery of high quality PV Agreements to ensure timely and accurate collection, safety review, processing and reporting of adverse event data in compliance with applicable global regulations and Jazz Pharmaceuticals standard operating procedures and guidelines. To this end, the PVAM Specialist guides and facilitates effective working relationships within R&D Global Pharmacovigilance and Labeling, and cross-functionally with strategic departments within the company and its affiliates/subsidiaries to foster smooth, accurate, and timely flow of activities related to PV Agreements (PVA)s as well as effective contractual relationships with PV Service Providers. The PVAM Specialist is versed on PVAs, Safety Reporting Plans (SRPs), PV Service Provider Agreements, and acts as key contact person for internal and external customers, managing these alliances directly and working with the PVAM Team as well as in partnership with cross-functional staff. Working with the PVAM Manager, the Specialist may negotiate and maintain Agreements, including maintenance and reporting of KPIs/SLAs and participate in vendor governance. The Specialist will be responsible for coordinating PV activities related to Global Expansion in Canada and US. The PVAM Specialist may assist in special projects as assigned by the Pharmacovigilance (PV) department management. The PVAM Specialists have a breadth of responsibilities which are prioritized within the PVAM Team, and may be assigned to: Business Development & Opportunities Global PV Vendor Services Regional PV Vendor Services PVAM Specialist responsibilities may include PV alliance activities such as, but not limited to: Serve as the liaison between Global Pharmacovigilance and cross functional organizations, acting as a Pharmacovigilance ambassador and domain expert as well as increasing awareness within Global Pharmacovigilance of cross-functional customer/stakeholder needs and dependencies, including PV Service providers. Support implementation for new partnerships and maintenance/change Support establishment and maintenance of PVAs/SRPs/SPOPs/WOs associated with new business initiatives and opportunities. Interact with business process owners for additional information to address questions in establishing a PVA/SRP/SPOP/WO. Coordinate the PVA/SRP review by the safety review team, summarize agreement comments, and participate in the negotiation of the agreement. Contribute to resolving conflicts at team level or higher and facilitate decision making within the team. Escalate issues utilizing governance models and standard communication plans. Coordinate implementation of Safety Reporting plans for programs with the potential to generate safety information. Coordinate PV activities associated with in/out-licensing and marketing authorizations/withdrawals in Canada and United States. Collaborate with the cross-functional groups that have responsibility for activities that may generate adverse events or safety information such as (not limited to) Business Alliance/Development, Commercial, Medical Affairs. Support collection of information required to update designated sections of the PSMF. Organize and moderate meetings and author minutes/discussion summaries. Solicit items for and set agendas. Send out draft minutes/summaries for comments to both internal Global Pharmacovigilance and external PV Service Providers, and distribute final summaries to all participants, as well as senior PVAM staff. Follow up with meeting participants on the resolution of action items from meetings. Maintain and organize internal PVAM files (Agreements, supporting documents, meeting minutes). Participate in maintaining PVAM Jazz Portal and Mailbox. Conduct ad hoc/special projects and analyses for PVAM management. PVAM Specialist Essential Functions Adheres to company templates and GxP guidelines for documentation and communications Ensures compliance with corporate and departmental policies, standard operating procedures, and timely completion of all assigned training Other duties as required to support PVAM team Participate in the development and maintenance of PVAM activity workflow processes, department policies, work instructions, standard operating procedures and training material when new and/or updated processes are introduced May serve as an individual contributor or a project manager for functional projects or workflows. May mentor other team members Participation in Inspections and Audits as identified, as well as active role in maintaining a business as usual inspection ready state of operating Takes responsibility for personal development and continuous improvement including keeping up to date with pharmacovigilance practices, legislation and guidelines. Work collaboratively with cross-functional teams to evaluate the performance, identify bottlenecks, minimize regulatory risks and recognize patterns of inefficiencies in current operational processes Collaborate effectively with Quality Assurance, Legal, and Project Management. Minimum Requirements BS/BA degree in health related or biological science related field 3 plus years of pharmaceutical drug safety/pharmacovigilance operations experience In depth knowledge of pharmacovigilance activities and processes, with a preference for experience in more than one PV functional area Knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS. Experience interacting with service providers or external business partners Excellent teamwork and interpersonal skills are required with ability to effectively collaborate with internal and external contacts, building strong sustainable relationships Excellent oral and written communication skills, demonstrating professional maturity, confidence and competence Ability to work effectively within a matrix organization to achieve desired outcomes Track record of effective decision-making; makes good business decisions and analyses problems from multiple perspectives Ability to work across cultures, including in a virtual environment Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook) Team Building, Motivating and Influencing Others without authority Promoting Innovation and Process Improvement Maintaining activities Negotiation skills Strong analytical skills Must demonstrate accountability for delivery of results and have good problem-solving and decision-making skills Must be able to manage their own work, with ability to prioritize, plan and organize work assignments while working under strict timelines Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
Position Overview Nektar has an exciting opportunity for a Sr. Director, Drug Safety to join their team. Overall responsibility for leading the Drug Safety Team and directing the safety surveillance of all company investigational drug products in development and for managing patient safety and meeting regulatory reporting requirements.. Actively participates in the oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Analyses changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implements appropriate safety updates and risk mitigation plans. Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities. Serves as medical safety expert for all products in various stages of development. Lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance servicses. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development and preparation of periodic and annual safety reports , investigator communications,product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Provides medical expert safety review input into all critical documents for clinical development of products. Helps select, develop,train, and evaluate personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads and directs the Drug Safety Team and all aspects of drug safety related to all company sponsored clinical development activities to manage patient safety and compliance with regulatory reporting requirements. Actively participates in oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services. Negotiates contracts, interacts and supervises the activities of contract organizations and consultants for pharmacovigilance services. Provides ongoing advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans. Provides oversight of all clinical safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. Manages compliance with SOPs, and FDA and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators. Serves as the medical safety expert for all products at all stages of clinical development (Phase 1, 2 and 3 and post-approval). Plays lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Supports drug safety function and effectively interfaces with all relevant cross functional departments and personnel to ensure safety training and compliance, and readiness level to pass internal/external audits. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Participates with other senior managers to establish strategic plans for the clinical development plan of investigational products. Provides medical expert safety review input into all critical documents for clinical development of products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, , INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. Helps recruit and select personnel, and provides training, development, coaching and regular performance review feedback to direct reports. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures departmental budgets and schedules meet corporate requirements. An MD degree is required. A minimum of 9 years of relevant drug safety experience is required. A minimum of 7 years previous management experience may be required. An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, Visio, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
01/28/2021
Full time
Position Overview Nektar has an exciting opportunity for a Sr. Director, Drug Safety to join their team. Overall responsibility for leading the Drug Safety Team and directing the safety surveillance of all company investigational drug products in development and for managing patient safety and meeting regulatory reporting requirements.. Actively participates in the oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Analyses changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implements appropriate safety updates and risk mitigation plans. Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities. Serves as medical safety expert for all products in various stages of development. Lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance servicses. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development and preparation of periodic and annual safety reports , investigator communications,product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Provides medical expert safety review input into all critical documents for clinical development of products. Helps select, develop,train, and evaluate personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads and directs the Drug Safety Team and all aspects of drug safety related to all company sponsored clinical development activities to manage patient safety and compliance with regulatory reporting requirements. Actively participates in oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services. Negotiates contracts, interacts and supervises the activities of contract organizations and consultants for pharmacovigilance services. Provides ongoing advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans. Provides oversight of all clinical safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. Manages compliance with SOPs, and FDA and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators. Serves as the medical safety expert for all products at all stages of clinical development (Phase 1, 2 and 3 and post-approval). Plays lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Supports drug safety function and effectively interfaces with all relevant cross functional departments and personnel to ensure safety training and compliance, and readiness level to pass internal/external audits. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Participates with other senior managers to establish strategic plans for the clinical development plan of investigational products. Provides medical expert safety review input into all critical documents for clinical development of products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, , INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. Helps recruit and select personnel, and provides training, development, coaching and regular performance review feedback to direct reports. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures departmental budgets and schedules meet corporate requirements. An MD degree is required. A minimum of 9 years of relevant drug safety experience is required. A minimum of 7 years previous management experience may be required. An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, Visio, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.
DIGITAL PROJECT MANAGER CLINICAL INFORMATICS (REMOTE) BOSTON, MA 100% remote with some travel to the Boston office Project Description: As a Digital Clinical Project Manager, you will be spearheading the execution of critical digital projects in support of our ambitious clinical digital roadmap. In this role, you will connect and lead various stakeholders and contributors to collaborate on digital clinical projects. Define and Lead Digital Clinical Projects. Coordinate and participate in requirement gathering and definition (Business Analysis). Establish and manage project timelines. Ensure project goals and means meet business objectives and deliver value in a timely fashion. Work collaboratively across the organization to gain alignment on project objectives and deliverables. Engage with Computer Systems Validation lead to support appropriate validation activities. Report on project progress and status. Required Skills: 7+ years' experience in digital project management in a GxP environment . Proven experience with numerous Clinical, Data Management, Regulatory and Pharmacovigilance systems. Veeva experience preferred. Working knowledge of CSV concepts for SaaS GxP applications . Tangible track record in using Agile approaches in a regulated environment . As a technologist, you know your craft and, you are fluent in the digital world. You have first-hand knowledge of SaaS technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials. You have a working knowledge of clinical operations, clinical data management, regulatory and safety business processes in a drug development context. You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward. You don't hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast pace environment, and you can navigate ambiguity and lead a team effectively . You put team before tasks by collaborating actively with all team members and supporting them. Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred. This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #20-00945 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR - provided by Dice
09/28/2020
Full time
DIGITAL PROJECT MANAGER CLINICAL INFORMATICS (REMOTE) BOSTON, MA 100% remote with some travel to the Boston office Project Description: As a Digital Clinical Project Manager, you will be spearheading the execution of critical digital projects in support of our ambitious clinical digital roadmap. In this role, you will connect and lead various stakeholders and contributors to collaborate on digital clinical projects. Define and Lead Digital Clinical Projects. Coordinate and participate in requirement gathering and definition (Business Analysis). Establish and manage project timelines. Ensure project goals and means meet business objectives and deliver value in a timely fashion. Work collaboratively across the organization to gain alignment on project objectives and deliverables. Engage with Computer Systems Validation lead to support appropriate validation activities. Report on project progress and status. Required Skills: 7+ years' experience in digital project management in a GxP environment . Proven experience with numerous Clinical, Data Management, Regulatory and Pharmacovigilance systems. Veeva experience preferred. Working knowledge of CSV concepts for SaaS GxP applications . Tangible track record in using Agile approaches in a regulated environment . As a technologist, you know your craft and, you are fluent in the digital world. You have first-hand knowledge of SaaS technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials. You have a working knowledge of clinical operations, clinical data management, regulatory and safety business processes in a drug development context. You work independently yet engage proactively with team members, colleagues and stakeholders to get alignment and drive projects forward. You don't hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast pace environment, and you can navigate ambiguity and lead a team effectively . You put team before tasks by collaborating actively with all team members and supporting them. Bachelor's degree in Computer Science, Biotechnology or equivalent required. Master's preferred. This 6+ month position starts ASAP. Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: ALPHA'S REQUIREMENT #20-00945 MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE #ZR - provided by Dice