Biotech/Pharmaceutical

Senior Manager Medical Writing – Remote

Permanent

Penfield Search Partners

Contact: Linda Aronova – laronova@penfieldsearch.com

Job Description: A Sr. Manager in the Global Regulatory Medical Writing department provides hands-on writing and/or basic-level oversight of outsourced-prepared clinical research documents for the Clinical Specialty Development organization (and other departments as appropriate). This role supports the areas of drug development and product registrations.

Essential Duties & Responsibilities:

  • Writes and/or edits clinical regulatory documents (all document types)
  • Provides contractor oversight for outsourced writing deliverables, and identifies, deploys and manages resources
  • Prepares or reviews and maintains document timelines
  • Oversees/Mentors for all document types and offers leadership and basic accountability, strategic assistance, and planning support at the product level for clinical regulatory documents
  • Ensures that clinical documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards
  • Aids medical writing (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays
  • Performs quality assurance review of documents and participates in meetings at the document team and clinical sub-team levels
  • Participates in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents
  • Uses various tools, business systems, and repositories
  • Exhibits competent collaboration, conflict-resolution, and influencing skills
  • May participate in the recruiting/hiring process

Qualifications

  • MSC/PhD degree in Life Sciences (or other related field), both with a minimum of 5 years writing experience of clinical regulatory documents in the Pharma/Biotech or CRO industry
  • Native level English [IL only]
  • Familiarity with the principles of clinical research and drug development, including clinical trial design, operations, and results analysis
  • Ability to prepare any type of regulatory document (CSR, Protocols, clinical sections for submissions)
  • Ability to interpret, communicate and write clinical data in a clear and concise manner
  • Proficient in MS Word and experience with document templates
  • Experience with an electronic document management system
  • Previous experience in project management
  • Ability to work independently

Tagged as: Senior Manager Medical Writing - Remote