An excellent opportunity has arisen to join a leading pharmaceutical company as a Senior Medical Writer.
The Senior Medical Writer develops study protocols and amendments, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), Investigator's Brochures (IBs) and other regulatory documents for our Oncology programs, ensuring compliance with international requirements. He/she manages the process of reviews, reconciliation of comments, document finalization and approval.
The Medical Writer works towards the timely development of these documents in agreement with deadlines set together with the Study Team, the Medical Director and the Regulatory Affairs Department.
Your Main responsibilities:
*Author clinical and regulatory documents such as study protocols and amendments, ICFs, CSRs, IBs, Pediatric Investigation Plans, Briefing Books, Requests of Product Specific Waivers, applications for Orphan Drug Designations, and responses to health authorities; the documents should be accurate, suited for the intended audience and easy to read.
*Be responsible for triggering annual IB reviews and potential updates.
*Collaborate closely with internal specialists/colleagues/departments to obtain/provide information, ensure smooth review process, incorporate editorial comments, and solve queries to present a 'finished' final document within the required deadline.
*Ensure understanding and implementation of international quality standards (ICH GCP) and internal company procedures.
*Facilitate document review meetings and discussions.
*Contribute to the development of project timelines.
*3-5 year of experience in writing protocols, protocol amendments, briefing books, study reports, Health Authority responses, IBs, CSRs, ICFs.
*Experience in early phase clinical development in Oncology.
*In-depth knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents.
*Working knowledge of the clinical drug development process, clinical trials design and biostatistics, with experience in integrating information into clinical-regulatory documents.
*Fluency in English and solid writing/editorial skills (understandable, at a level appropri-ate to the audience and the project).
*Experience with effectively managing vendors and contract writers to meet time-lines/project objectives.
Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.
Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +44 1727 817623 or email: email@example.com
Tel: +41 4350 86620 or email: firstname.lastname@example.org
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