Associate Director, Medical Review

Takeda • USA - MA - Virtual, MA

3d • Remote

About The Position

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Medical Review. This is a Remote based position. 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. As an Associate Director, Medical Review within US Medical, you will be empowered to deliver high-quality, balanced and timely medical and scientific information regarding assigned products and serve as a technical and/or operational expert. In this role, you will contribute to Takeda’s mission.

Requirements

• Have a doctoral degree in a health sciences related field such as a PharmD, MD or Ph.D., with a thorough grasp of the pharmaceutical industry and the medical review role.
• 3-5 years of healthcare or related experience (managed markets, clinical practice, research or academic) following a doctoral degree including a minimum of 2 years of medical review experience within the pharmaceutical industry.
• Demonstrates advanced communication skills, both oral and written, and able to earn the trust and respect of peers, direct reports, and senior leaders.
• Well-versed in highly technical and scientific language to enable clear and effective communication with key internal and external stakeholders.
• Firm understanding of the drug development process including key phases, processes, and methods utilized for both pre- and post-marketing research studies.
• Firm understanding of guidelines pertaining to promotional materials and scientific exchange.
• Proven track record of teamwork, leadership, timely decision making and results orientation in meeting objectives.
• Proficiency in Veeva Vault and Microsoft Office applications including Word, Excel, PowerPoint, and Outlook.

Nice To Haves

• Therapeutic area experience
• Clinical, research, or teaching experience
• Board Certification in therapeutic area of interest
• Completion of pharmaceutical industry related residency or fellowship

Responsibilities

• Deliver high-quality, balanced and timely medical and scientific information regarding assigned products/therapeutic area and serve as a technical and/or operational expert
• Provide advanced medical and scientific review for promotional materials, press releases, and sales training communications
• Provide advanced medical and scientific review for non-promotional medical materials and others as identified
• Serve as an experienced medical and scientific expert to internal stakeholders, including Medical Team(s), Brand Team(s), Regulatory Advertising and Promotion, Legal and others.
• Actively participates, supports, and contributes to assigned Medical, Regulatory, and Legal cross-functional teams in promotional review
• Serves as an experienced medical expert and collaborator for other non-medical internal stakeholders as it pertains to medical review and/or other identified commercial and corporate needs
• Grants formal approval via signature authority for the cross-functional promotional review activities including: 1) providing strategic scientific consults on brand messages and content, 2) reviewing promotional materials for content and accuracy, and 3) coordinating the development, review, and approval of clinical data on file to support promotional claims
• Maintains current awareness on industry standards and regulations, shares insights and applies best practices to promotional review and other related activities
• Provides medical review for identified medical and other non-promotional materials as requested
• Maintains current knowledge of assigned disease state, product, competitors, and other relevant medical and scientific developments
• Participates in assigned medical, brand, or company related meetings as requested

Benefits

• 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
• well-being benefits
• up to 80 hours of sick time
• up to 120 hours of paid vacation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree