Manager, Medical Writing
- We are parntered with an esteemed pharmaceutical company is seeking a dynamic and experienced Senior Manager of Regulatory Medical Writing to join their Regulatory Affairs team. The successful candidate will play a pivotal role in leading the development and execution of regulatory medical writing strategies within the Gastrointestinal (GI) and Immunology therapeutic areas. This position requires a seasoned professional with a deep understanding of regulatory requirements, exceptional leadership skills, and a proven track record in regulatory medical writing.
- Provide strategic direction and oversight for regulatory medical writing activities in the GI and Immunology space.
- Collaborate with cross-functional teams to ensure alignment of regulatory medical writing plans with overall regulatory strategies.
- Direct the planning, preparation, and review of regulatory documents, including but not limited to Clinical Study Reports (CSRs), Investigator's Brochures (IBs), and Regulatory Authority Briefing Books.
- Ensure compliance with regulatory requirements and adherence to company standards.
Regulatory Submission Support:
- Provide expertise in the preparation and submission of regulatory documents to health authorities, including New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and variations/amendments.
- Collaborate with Regulatory Affairs to ensure timely and successful submissions.
- Act as a liaison between the medical writing team and external partners, such as Contract Research Organizations (CROs) and regulatory agencies.
- Advanced degree in a relevant scientific discipline (PhD, PharmD, or equivalent).
- Minimum 4 years of experience in regulatory medical writing within the pharmaceutical industry, with a focus on GI and Immunology.
- Proven leadership experience managing a team of medical writers.
- In-depth knowledge of global regulatory requirements and guidelines.
- Strong interpersonal and communication skills, with the ability to collaborate effectively across functions.