Medical Writer
Posted 7 days ago by Planet Pharma
Negotiable
Undetermined
Undetermined
United Kingdom
Summary: The Medical Writer role at Planet Pharma involves leading the authoring of high-complexity clinical documents for regulatory submissions within a globally renowned clinical research organization. The position requires strong project management and stakeholder management skills, as well as proven experience in medical writing for clinical studies. This opportunity allows for significant contributions to the development of innovative therapies across diverse therapeutic areas. The role is based in the United Kingdom and is part of a respected CRO recognized for its commitment to excellence in staffing services.
Key Responsibilities:
- Author high-complexity study-level documents including protocols, informed consent forms, investigator brochures, and meeting packages.
- Prepare clinical evaluation plans and clinical evaluation reports.
- Develop clinical summaries and overviews in CTD/eCTD formats for global regulatory submissions.
Key Skills:
- Proven experience in Phase I-III protocol and Clinical Study Report (CSR) medical writing.
- Strong stakeholder management skills.
- Solid project management and leadership experience.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Medical Writer – Global Clinical Research Organisation
Planet Pharma is collaborating with a globally renowned clinical research organisation (CRO) to recruit an experienced Medical Writer. This role offers the opportunity to contribute to the preparation of regulatory submissions and other complex clinical documents, playing a key part in bringing innovative therapies to market.
Role Overview:
As a Medical Writer, you will take the lead in authoring high-complexity study-level documents, including:
- Protocols, Informed Consent Forms (ICFs), Investigator Brochures, and Meeting Packages
- Clinical Evaluation Plans and Clinical Evaluation Reports
- Clinical Summaries and Overviews in CTD/eCTD formats for global regulatory submissions
Key Requirements:
We are looking for an experienced medical writer with a strong track record in leading medical writing projects. The ideal candidate will have:
- Proven experience in Phase I-III protocol and Clinical Study Report (CSR) medical writing
- Strong stakeholder management skills, working effectively with internal and external teams
- Solid project management and leadership experience
This is a fantastic opportunity to join a respected CRO, work across diverse therapeutic areas, and play a pivotal role in the development of groundbreaking treatments.
About Planet Pharma:
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognized by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.