Senior Medical Content Strategist
6 hours ago
About the Role
We are seeking a highly motivated and experienced Senior Medical Content Strategist to join our team at Genmab. In this role, you will serve as an expert in planning, developing, and writing complex clinical documents to support medical and regulatory activities across our portfolio.
The ideal candidate will have a strong academic background in life sciences and at least 10 years of experience in medical or scientific writing, preferably in the pharmaceutical industry. You will be responsible for leading cross-functional teams, managing vendors/CROs, and driving strategic initiatives to ensure high-quality deliverables.
Key Responsibilities
- Develop and execute strategies for planning and authoring complex clinical and regulatory documents, including protocols, investigator's brochures, and clinical study reports.
- Serve as a subject matter expert, guiding teams during document planning and authoring stages, and facilitating contributor/review meetings.
- Lead the development of processes and templates for continuous process improvement and maintaining high quality standards.
- Closely coordinate with internal project teams and departments to ensure timely completion of tasks with desired quality.
- Collaborate with CROs/vendors to assist with project planning and resourcing planning.
Requirements - What You Must Have
- BA/BS degree in life sciences and at least 10 years' medical or scientific writing experience, preferably in the pharmaceutical industry.
- Extensive experience writing protocols, investigator's brochures, clinical study reports, Health Authority briefing packages, and clinical submission documents.
- Expert understanding and knowledge of regulatory requirements and drug development processes, Good Clinical Practice (GCP), and regulatory requirements associated with regulatory documents.
- Strong analytical skills, ability to interpret and summarize complex tabular and graphical data presentations.
- Proficiency in computer software, including word processing, graphics, and reference manager tools.
About You
- You are self-driven, collaborative, and thrive working on multiple tasks with shifting priorities.
- You have excellent oral and written communication skills, and are proactive, open-minded, and result-oriented.
- You have experience working in fast-paced, dynamic environments, and are not afraid to innovate and try new approaches.
Location and Salary
We offer competitive salaries ranging from $145,000 to $180,000 per year, depending on your location and qualifications.
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