Pre-Clinical Medical Writer
Life Sciences Pharmaceuticals
CY Partners have an exciting opportunity for a Pre – Clinical Medical Writer to join a global Pharmaceutical organisation, this role will initially be home based, but some travel to the organisations site in Surrey may be required moving forward.
As a Pre-Clinical Medical Writer you will provide preclinical subject matter expertise to support medical writing activities for product lifecycle management and regulatory submissions.
• Provide preclinical expertise to support to the development of nonclinical overviews and summaries (e.g. nonclinical CTD modules 2.4, 2.6.x) to support registration renewals and new license applications.
• Provide preclinical contributions to required response documents to address requests from Health Authorities and affiliates.
• Accountable for the delivery of assigned medical writing projects to a submission-ready standard.
• Develop requests for proposals (RFPs), vendor oversight plans and task orders in partnership with contract managers to facilitate the outsourcing of medical writing activities to preferred vendors.
• Actively participate in internal project management meetings as necessary to provide updates and communicate risks and issues.
• Single point of contact between the organisation and preferred medical writing vendors on assigned projects.
• Coordinate key meetings with medical writing vendors and the organisations functional contributors (e.g. regulatory affairs, safety, toxicology etc.) per standard operating procedures (SOPs).
• Input into the literature search strategy for assigned nonclinical CTD modules.
• Provide in-house source data (e.g. previous nonclinical CTD modules, nonclinical study reports, templates, company data sheets etc.) to medical writing vendors as needed.
• Coordinate the review, quality control and approval process for assigned nonclinical documents.
To find out more about the role please contact Helen at CY Partners on 07851246847 or email your CV to [email protected] to apply.