Medical Writer - Early phases at PPD

Medical Writer - Early phases

• Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.
• May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Ensures compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results.
• May assist in program management activities. Duties could include assisting with developing timelines, budgets, forecasts for assigned deliverables.
• Represents the department at project launch meetings, review meetings, and project team meetings.

Qualifications Required

• Education to Bachelor’s/advanced degree level in a scientific discipline
• 3+ years of experience within regulatory medical writing
• Excellent grammatical, editorial and proofreading skills
• CSR (clinical study report) early development study designs; Ib/2a patient-population experience
• Protocol development/early development study designs; Ib/2a patient-population experience
• ICH proficiency a must

Preferred Qualifications

• Industry guidance for Ph I/early development study designs
• Previous CRO experience

Skills And Knowledge Required

• Strong project management skills
• Strong decision-making, critical thinking and priortization skills
• Experience managing and delivering according to strict deadlines
• Ability to manage competing priorities

The successful candidate can look forward to job stability with a leading CRO that has experienced year-on-year growth. We offer a generous salary and benefits package as well as excellent learning and development opportunities. We understand that the best writers are not necessarily on our doorstep, so if you are looking for a home-based role we can offer this option to the right candidate, providing everything you need to fulfil your potential from your home office.
How to apply: Submit your CV in English.

PPD is equal opportunities employer.
Organization

• Medical Writing

Primary Location

• Europe, Middle East & Africa

Other Locations

• GB-United Kingdom, ZA-South Africa