Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job 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.