• 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

• 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.