Associate Director, Global Regulatory Affairs – Advertising and Promotion Review Lead

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October 28

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

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Takeda

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Takeda is a global biopharmaceutical company dedicated to bringing better health and a brighter future to patients worldwide. With a strong focus on research and development, manufacturing, and quality, Takeda operates with a commitment to ethics and a diverse workforce that spans over 80 countries. The company leverages innovative science and partnerships to create impactful medicines, including therapies in oncology and vaccines, ensuring that they effectively meet the needs of the patients they serve.

10,000+ employees

Founded 1781

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Grant on 2016-08

📋 Description

• Serve as GRA A&P SME for assigned products and projects. • Regulatory advisor as the “R” in the core Medical, Legal, Regulatory review functions of the Commercial Material Review Process (CMRP) and Medical Material Review Process (MMRP) for both Commercial and Medical material development, review, approval, and implementation. • Product or project business lead for global CMRP at Takeda. • CMRP Meeting Chair- pausing to communicate comments to coordinator, diffusing team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders which are the patients who trust us to do the right thing, and overseeing escalation steps if MLR cannot come to alignment or if there is new data or campaigns that require senior level management input or alignment. • Strategic business partner from clinical trial development through the marketing maintenance phase of a product lifecycle. • Subject matter expert on FDA code/regs, guidance, industry standards, complaints/violations, and innovative promotional platforms with additional training on International Codes (e.g.) EFPIA, IFPMA) and guidelines for Global product support. • Partner closely with line-management, Oncology GRA A&P Portfolio Lead and inform or bring in Head of GRA A&P for complex review concepts or topics. • Empowered decision-maker within the CMRP.

🎯 Requirements

• Bachelor's Degree in a science-related field is required. • Master's Degree preferred. • Minimum of 3 years’ experience required in material review and approval process of pharmaceutical/biologics promotion. • Ability to understand ABPI, EFPIA and other international code and guidance about advertising and promotion for prescription medicines. • Experience in prescription medicine promotion development and review process. • Strong interpersonal skills with ability to demonstrate strategic and analytic thinking. • Demonstrated ability to communicate clearly and concisely. • Highly effective written and verbal communication skills to manage, motivate and drive decisions within teams. • Proven skills in negotiation, influencing without authority and working diplomatically through conflict. • Demonstrated cross-functional people management with a desire to foster a positive team culture. • Ability to work independently, take initiative and complete tasks to deadlines. • Previous experience in an advertising and promotion role.

🏖️ Benefits

• U.S. based employees may be eligible for short-term and/ or long-term incentives. • U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. • U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.