Manager, Medical Affairs – Clinical Nutrition

Role Overview

• Serve as the Medical reviewer at the Medical-Legal-Regulatory (MLR) review team for the US Clinical Nutrition team.
• Lead the management and oversight of Medical Information and medical affairs including new product launches for Clinical Nutrition team.
• Collaborate with the other medical affairs team members to provide expertise and support on a broad range of activities including medical communication, medical training, congress strategy and execution, and data generation and clinical education across Clinical Nutrition portfolio.
• Develop, maintain, and update standard response letters (SRLs), FAQs, and other medical information resources to ensure consistency and compliance with regulatory requirements.
• Collaborate with cross-functional teams to review product labeling, ensuring alignment with scientific evidence, regulatory standards, and therapeutic needs.
• Provide medical expertise to commercial, regulatory, and clinical teams for the launch and life-cycle management of clinical nutrition products.
• Prepare medical content for presentations, educational materials, and advisory boards as needed.
• Provide operational support to the US Clinical Nutrition Medical Affairs team including managing team projects, timelines, and budget, contracting, and vendor management.
• Collaborate with the Global Medical, Clinical, and Regulatory Affairs in the management of US-based clinical trials including regulatory requests and PMRs.

Requirements

• Advanced qualification as a Registered Dietitian (RD/RDN) or a Master’s degree in a relevant clinical discipline (nutrition)
• 5+ years of overall experience
• 3+ years of experience in Medical Affairs
• 2+ years of experience as Medical Reviewer in Medical-Legal-Regulatory review (MLR)
• Demonstrated knowledge in nutrition care is strongly preferred
• Demonstrated skill in interpreting and writing scientific documents.
• Knowledge of pharmaceutical product development and clinical trial design processes
• Knowledge of US Healthcare system including reimbursement and access to pharmaceuticals, medical food, and supplemental therapies
• Excellent communication (both written and verbal) and presentation skills – capacity to translate complex clinical information in concise verbal and written description.

Benefits

• 401(k) plan with company contributions
• paid vacation
• holiday and personal days
• employee assistance program
• health benefits to include medical, prescription drug, dental and vision coverage