What are the responsibilities and job description for the Senior Medical Writer - Remote position at Penfield Search Partners?
Contact : Alexandra Spink, aspink@penfieldsearch.com
No 3rd party agencies
Job Description : A full-time contractor 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.
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.
Requirements :
