IA&P Customer Excellence and Process Adherence Lead - Global Regulatory Affairs

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Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an IA&P Customer Excellence and Process Adherence Lead - Global Regulatory Affairs in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION ACCOUNTABILITIES:

• Develops appropriate tools to measure system adherence, assess risks and evaluate opportunities and makes recommendations based on findings
• Works closely with key stakeholders responsible for the Learning Management System to ensure system access and training adherence are aligned
• Works closely with key stakeholders responsible for Quality and Compliance, to ensure audit and inspection processes are aligned and accountabilities in IA&P are well defined
• Develop innovative on and off-boarding procedures to ensure streamlined user experience is guar-anteed.
• Designs, develops, and implements communication and guidance tools which create a positive customer experience and promote service excellence
• Proactively identify opportunities to increase service levels and mitigate any issues in service delivery within the function or across functions
• Supports the A&P Business Solutions team to focus on the overall priorities for the business, to maximize customer satisfaction
• Report back on external agencies performance and potential areas of improvement
• Inputs to our architectural operations vision: Align multiple systems/processes across IA&P and the broader community in collaboration with Product Owner and IA&P Leadership
• Support IA&P endeavors, for projects to be successfully delivered on-time, within scope and within budget
• Assists in the definition of project scope and objectives, involving all relevant stakeholders and ensuring monitoring and adherence feasibility

DIMENSIONS AND ASPECTS:
Technical/Functional (Line) Expertise

• Credible engagement with Quality and Compliance functions and internal LOC stakeholders to drive compliance and monitoring in the technical roadmap
• Be an expert / SME in EAS, DAM and Brand Portals technical development
• Understand the phases, processes and techniques used within a regulatory environment
• Demonstrate excellent planning, time management and scheduling skills for self and others contributing to the technical roadmap

Leadership

• Influence others at all levels & works collaboratively across different Global functions and LOCs.
• Strong ability to recognize and consider interdependencies of requirements and changing needs of a fast paced and dynamically complex business, translate to solutions, communicate same at a senior level
• Work collaboratively in a cross-functional team environment, across multiple time zones
• Represent IA&P and GRA in a positive and professional manner at all times

Decision-making and Autonomy

• Take initiative and coordinate resources to drive tasks to deadlines
• Demonstrate technical solutioning skills, working with the Review Team and other identified parties, to drive proposals to anticipate and meet demand, influence decision making to feasible solutions
• Use collaboration skills and partnerships to work within the agreed Governance Model

Interaction

• Confidently engage with external vendors and manage internal Global stakeholders, representing the needs of the business and those of IA&P and our internal partners
• Express self clearly and concisely at all levels, in both verbal and written communication
• Demonstrate maturity of thinking
• Embrace diversity, adapt to other personalities in a respectful manner that is conducive to goal achievement
• Create and deliver clear

Innovation

• Establish the overall vision with the relevant stakeholders, working with Vendors and developers to ensure the EAS and Brand Portals are integral to the overall solution in support of the BU's.
• Identifies and gains agreement for reporting, monitoring and adherence Tools and Features for the EAS and Brand Portals, including Multichannel Marketing capabilities, within the appropriate Governance Model.
• Works closely with relevant support teams as SME input on the existing EAS and Brand Portals and to define the support tools and enhancements to match our roadmap for the future

Complexity

• Understand the changing needs and priorities of the business
• Understand complex issues and to propose timely, cost effective and achievable solutions, whilst being mindful of flexibility rather than a 'one size fits all' approach
• Work in a fast paced environment with demonstrated ability to delegate & juggle multiple competing tasks and demands, often with a degree of ambiguity

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• Bachelor Degree or above 8+ years technical experience in Electronic Approval System/s for the Healthcare/Pharmaceutical industry or 8+ years experience in successful technical project delivery & operational effectiveness (ideally in IT/Integration/Business Operations projects) with 4+ years experience working in drug, biologic, device, Regulatory Affairs or related field or equivalent from another highly regulated industry
• 4+ years working with or within a Quality and /or Compliance function
• 2+ years working with audit and inspection procedures
• Strong analytical skills: working knowledge of business needs assessments, business case proposals
• Excellent client-facing and internal written and verbal communication skills
• Solid organizational skills including attention to detail and multitasking skills
• Strong working knowledge of Microsoft Office

Desired:

• Considerable knowledge of change management & dealing with complex and dynamic business environments, including integration projects
• Good working knowledge of Global copyright laws/Data Privacy Legislation/Software Licensing Restriction
• Ability to understand operational processes, EFPIA and International (ex-US) regulation basics on advertising and promotion for prescription products/basics in pharmaceutical promotion development
• Excellent English verbal and written communication skills, fluency in another European language beneficial
• Direct knowledge of Veeva/cloud solutions
• Experience of working within an AGILE Framework is a plus

WHAT TAKEDA CAN OFFER YOU:

• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations
Boston, MA

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time