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.