Job Description

Contact: Alexandra Spink – aspink@penfieldsearch.com

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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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