An amazing home-based opportunity has arisen for a Medical Writer anywhere in Europe. This is an amazing chance to develop and diversify your portfolio and join a brilliant biopharmaceutical company.
- Write clinical documents for submission to regulatory authorities, including briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, integrated summaries of safety and efficacy.
- Serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues.
- Serve as the Medical Writing representative on assigned project teams.
- Providing proactive support to Project Leadership for planning efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
- Coordinate production and distribution of draft and final documents to project team and client.
Skills and Requirements
- Degree level in Life Sciences/Health Related Sciences or equivalent.
- Experience in writing multiple clinical study reports, and either CTD documents or study protocols.
- Preferably experience in a variety of therapy areas
- Experience with a variety of documents (CSRs, IBs, protocol/amendments, briefing books, HA responses, post-submission safety updates, and preferably submissions [clinical CTD modules].
- Excellent interpersonal, verbal and written communication skills.
- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
- Fluency in English (written and spoken) is required.
In case you have difficulty in applying or if you have any questions, please contact Tom Russell on +44 203 8246 104 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.