A leading pharmaceutical client is searching for a Medical Writer to join their team in Hertfordshire, UK. The company specialises in various therapy areas including oncology, neurology and gastroenterology, and employs several thousand across the globe. This Medical Writer role is on a contract and the incumbent must be in the office 3 days per week.
- The medical writer is expected to work directly with clinical study teams, the oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents.
- Should be able to prepare regulatory documents on behalf of the company in accordance with the ICH guidelines, international regulations, the company's standards and processes, and the company Writing Style Guide as applicable.
- Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator Brochures, and submission documents.
- Responsible for managing the document review process. Route documents for approval.
- The medical writer will be expected to format and manage long documents with multiple review cycles and tight deadlines.
- As a representative of the core oncology medical writing group, act as a liaison between the UK teams and the MW group in US.
- Participate in project team meetings to provide input regarding deliverables, timelines, and processes, consistent with the the company's global practices as adopted by the oncology medical writing group.
- Inform the director about the medical writing needs in UK.
- Help to ensure procurement of adequate and quality resources to complete EU-specific medical writing deliverables.
- At the director's discretion, offer guidance to these external vendors.
Skills and Experience:
- Demonstrated experience of writing regulatory documents in the pharmaceutical industry.
- Prior experience in oncology is a plus.
- The ability to independently write regulatory documents in collaboration with the various members of study team.
- Excellent writing skills, meticulous attention to detail, proficiency using an electronic document management system, and strong analytical ability to interpret clinical data.
- The medical writer should be familiar with ICH guidelines and the current AMA Style Manual.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Lisa Edgar on +44 203 7520 313 or upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.