Senior Medical Writer
4 weeks ago
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:
- 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.
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