PK Medical Writer
RemoteUnited Kingdom or Poland
Job Summary
Lead the development and execution of medical writing strategies for clinical research projects, delivering high-quality Clinical Pharmacology & Pharmacometrics documents including population PK/PD data transfer plans, analysis plans, reports, CSRs, and protocols. Drive the document preparation process by reviewing primary statistical output, drafting documents for review, and incorporating comments from all reviewers. Provide scientific consultancy to project teams while ensuring deliverables adhere to client SOPs, regulatory requirements, and ICH-GCP standards. Maintain central planning of document writing and QC deliverables to ensure inspection readiness. This senior role supports the advancement of innovative treatments within a global healthcare intelligence organization, requiring a life sciences background and experience in the pharmaceutical or CRO industry.
Required Qualifications
- Advanced degree in Life Sciences, Pharmacy, Medicine, or related field
- Minimum of 3-5 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry
- Proficiency in interpreting and summarizing complex clinical trial data, scientific research findings, and statistical analyses
- Excellent writing, editing, and proofreading skills
- Ability to communicate scientific concepts to diverse audiences
- Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications
- Experience in interacting with regulatory agencies during the review and approval process
- Ability to work effectively in a fast-paced, deadline-driven environment
- Ability to manage multiple projects simultaneously
- Ability to prioritize tasks based on project timelines and deliverables
- Excellent interpersonal and communication skills
- Ability to collaborate effectively with cross-functional teams
- Ability to build relationships with key stakeholders
- Ability to influence decision-making processes
- Legal right to work in the country where the role is based
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