Lifelancer
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.
Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.
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Lifelancer
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