Job Description

Responsibilities:

• Produce well-written, high-quality, timely Medical Writing documents (like Clinical Study Reports, Protocols and amendments, Investigator\'s Brochure [IB] and IB updates, etc)
• Review (including peer and QC review) Medical Writing documents in accordance with current SOPs, ensuring checklists and tracking documents are completed
• Proof-read and provide editorial support on documents produced by other departments in company or by clients, if requested
• Provide oversight on Medical Writing projects and/or cross-functional projects using project management tools and processes
• Manage the document review process ensuring conflicting and/or ambiguous comments are clarified and adequately addressed
• Assist Principal Medical Writers and above with the management of department budget and financials
• Actively contribute to business development by keeping CV up-to-date, preparing and reviewing client proposals and other business development documentation, as well as presenting at client meetings and bid defense meetings
• Line manage assigned personnel taking an active role in their development and provide guidance and mentorship to less experienced Medical Writers
• Conduct literature reviews and provide input on the development of scientific communication and messaging
• Manage timelines and deliver documents within established deadlines

Requirements

• Master\'s degree or higher in a life science or related field.
• Minimum 5 years of experience as a Medical Writer in the pharmaceutical, biotechnology, or CRO industry.
• Strong knowledge of clinical research, regulatory requirements, and industry guidelines (ICH-GCP).
• Excellent writing, editing, and proofreading skills, with the ability to communicate complex scientific information effectively.
• Experience in writing clinical study documents, such as protocols, clinical study reports, and regulatory submission documents.
• Detail-oriented with excellent organizational and time management skills.
• Ability to work independently and collaboratively in a team environment.

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