Senior Medical Writer

Job Reference: #64023 Add to saved jobs

  • Salary $120000 - 130000
  • Location Remote
  • Permanent
  • Sector Pharmaceuticals

Job Summary

Meet's top Biopharma client has engaged us on an EXCLUSIVE new search for a talented Senior Medical Writer. This role can be fully-remote based and will be leading the completion of regulatory documents in support of their extensive development pipeline (Virology, Immunology, Oncology, Rheumatology etc.). This is an excellent opportunity for someone looking for flexibility within a leading Biopharma sponsor and to work on exciting products at various life cycle stages. 

Job Overview

• Handles all components of writing clinical and non-clinical regulatory documents including but not limited to CSRs, Protocols, IBs, major BLA/IND/NDA submissions and (e)CTD Module documents

• Independently resolves document content issues and questions arising during the writing. process

• Maintains strict timelines for all clinical/nonclinical documents

• Acts as Subject Matter Expert for assigned clinical teams and liaises with internal and external departments effectively

• Assures document completion in accordance with ICH and other regulatory guidelines

• Navigates team dynamics and drives timelines as a project lead

• Explains data in a manner consistent with clinical regulatory requirements

• Confirms completeness of information to be presented, Challenges conclusions when necessary

• Arranges, conducts and leads team review meetings throughout project progression

Skills Required

• Minimum of 3 years in the pharmaceutical industry

• 2-3+ years of experience writing clinical and regulatory documents

• Advanced Degree in Life Sciences, PhD preferred, Professional Medical Writing certification (e.g., AMWA, EMWA, RAPS) an advantage, but not mandatory

• Expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions

• Exceptional writing ability with strong attention to grammar and punctuation details

• Pharma or CRO experience

Contact Details

Please contact Meghan McCann on +1 646-569-9081 or email meghan@peoplewithchemistry.com if you would like to know more about this opportunity. This will be 100% confidential.

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