Principal Medical Writer

Meet in Roxbury, MA

  • Industry: Pharmaceutical/Biotechnology - Others
  • Type: Full Time
position filled
Principal Medical Writer My client is a global pharmaceutical company that specializes in research and development, manufacturing, market commercialization, and import and export of consumer health care products and pharmaceutical drugs. Offering a vast variety of products within photographic chmicals, vitamin bulks, clinical diagnostics, and test reagents, my client aspires to create better health as well as better futures for individuals throughout the world. My client is looking for a Principal Medical Writer to join their team who has at least 4 years of relevant industry experience. This is a full time, fully remote role with a competitive salary. Role Responsibilities: Lead a team guiding medical writing activites within a specific therapeutic area for regulatory submissions and key response documents. Provide expertise including organization, content, timelines, and resourcer requirements. Serve as lead writer for strategic regulatory documents and important aspects of regulatory submissions. Coordinate and provide oversight of the activities of medical writing vendors and resolve issues. Provide complex and advanced input for study designs, analysis plans, INDs, and marketing applications. Role Requirements: BS in science, health profession, or journalism required. Minimum 5 years experience writing for biotech or pharma. Demonstrated understanding of FDA/international regulations, ICH guidelines, and US/international regulatory processes in regards to document prepatation and production. Expert knowledge of clinical development including but not limited to the phases, processes, and techniques used within clinical development. Excellent oral and written communication skills and the ability to clearly present technical information across functional areas. Please contact Emma Vagedes-Plavcan at +1 646-569-9081 or email if you would like to know more about this opportunity

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