The role of the Senior Medical Writer is to author high quality documents for multiple client projects, including, as appropriate; drugs, biologics, Advanced Therapy Medicinal Products (Cell-, Gene- and Tissue therapies) and to deliver high quality documents in a timely manner.
Principal roles and responsibilities will mainly include:- Act as medical writing lead on complex client programs, ensuring the highest quality of deliverable;
- Review of draft and final documents prepared by VCLS consultants or clients before internal or external distribution. This includes editing, and quality checking as appropriate;
- Ensure that the documents' content and style are in-line with the required regulation standards and guidelines, and comply with either; VCLS, or client SOPs/in-house style requirements;
- Draft and/or review clinical and regulatory documents including clinical study protocols/amendments, investigator brochures, clinical study reports, clinical summaries and clinical overview;
- Contribute to the writing of other regulatory documents e.g. Orphan Drug Designation applications, Pediatric Investigation Plans, etc.;
- Help define a projects’ scope of work and provide input into related cost estimates.
Requirements
- A highly motivated and experienced individual with a proven track record in effective Medical Writing with a minimum of 6 - 8+ years’ experience;
- Experience with ICH guidelines, Common Technical Documents (CTD) and other applicable EU amp; US regulatory guidance;
- Experience with research tools and approaches, such as reference management/publication planning databases.
skills, including MS Office, Outlook and Internet.