Indegene

Medical Review Manager (MD is required)

Summary: Indegene is looking for a US-based Medical Affairs Professional with Medical Review experience to serve as medical representative as part of the US Medical, Legal, Regulatory (MLR) review team.

Responsibilities:

• Serve as the medical delegate on US Medical, Legal, and Regulatory (MLR) review committee, which is responsible for review and approval (Sign off) of all promotional and medical materials containing information on pharmaceutical company’s marketed products and compounds in development, as well as the corresponding disease states developed for US markets.
• Review materials and ensure data included are accurate, within context, and presented in a fair/scientifically-balanced manner. Verify substantiation of all claims and comparisons. Determine acceptability of references, advise on whether claims are consistent with appropriate approved label, and ensure that the piece is relevant and of utility for the target audience.
• Advise on materials and events designed and produced by US marketing and medical teams to ensure compliance with company policies and global standards for ethical promotion and scientific interactions.
• Support US marketing and medical colleagues through guidance and provision of information on company products, brand messages and claims that are in compliance with US regulations.
• Ensure standards for promotional claims and non-promotional product information sharing, ensuring promotions and communications adhere to regulations and support appropriate use of products.
• Work collaboratively and develop a good working relationship with the Medical Affairs Leads and Medical Directors to ensure alignment of company medical strategy. This includes escalating materials accordingly when guidance is required.

Requirements:

Educational and experience related:

• Candidate with medical degree/medical doctor qualification (MD)
• 3-5 years of industry experience in Pharmaceuticals within medical affairs, medical communications, or medical information teams
• US board certified medical professional with good clinical experience preferred, internal medicine specialist with specialization in pain management will be preferred
• 1-2 years of prior work experience working as a medical delegate in the pharma MLR committee (providing medical sign-off on Promotional and Non-promotional materials)

Additional work related:

• Can work as collaborative team member who provides compliant, medically accurate solutions - while improving marketing messages for consumer, healthcare provider and managed care materials. Strong ability to work independently, with flexibility and a strong ability to connect and work with multidisciplinary teams
• Good understanding of FDA and international regulations on advertising, promotion and scientific exchange.
• Familiarity with Veeva PromoMats and Veeva MedComms platforms preferred
• Excellent multitasking, project management, organizational skills and attention to detail
• Solution oriented, positive attitude and excellent interpersonal skills; as well as oral and written communication skills.
• Experience working as part of a multi-national teams
• Ability to work cross-functionally with marketing, legal, regulatory, medical affairs