FSP Associate Medical Writing Director (EMEA)
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Job Location:
Monthly Salary:
Posted on:
10 hours ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Position Overview:We are seeking a highly skilled and experienced professional in Europe to oversee clinical pharmacology deliverables and serve as an ESA Subject Matter Expert (SME). The ideal candidate will have a strong background in medical writing peer review and coaching with specific expertise in early phase protocol development and ESA management.
Key Responsibilities:
Clinical Pharmacology Oversight:
- Oversee the development and delivery of clinical pharmacology deliverables including but not limited to 2.7.1 2.7.2 and ESAs.
- Conduct peer reviews and provide coaching to writers to ensure high-quality outputs.
- Experience of managing early phase assets.
- Act as the primary point of contact for planning and resourcing ESA requests.
- Lead the development of clinical pharmacology RACIs and establish effective ways of working.
- Support the development and rollout of early phase protocol including developing/refining long-term monitoring feedback and update plans.
- Serve as a medical writing reviewer for clin pharm template updates.
- Review clin pharm documents to ensure compliance with client style guides.
- Pilot and assess the capabilities of medical writers to lead clin pharm documents.
Key Requirements:
- Proven experience in clinical pharmacology deliverable oversight and medical writing.
- Expertise in ESA management and protocol development.
- Strong leadership and coaching skills.
- Excellent communication and organizational skills.
- Ability to work collaboratively with cross-functional teams.
- Familiarity with early phase clinical studies and regulatory requirements.
Preferred Experience:
Working in an FTE role.
Required Experience:
Director
Key Skills
- EMR Systems
- Post Residency Experience
- Occupational Health Experience
- Clinical Research
- Managed Care
- Primary Care Experience
- Medical Management
- Utilization Management
- Clinical Development
- Clinical Trials
- Leadership Experience
- Medicare
About Company
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