Preclinical Medical Writer
Executive Life Sciences Pharmaceuticals
CY Partners have a rare and exciting opportunity for a Principal Preclinical Medical Writer to join a world leading healthcare organisation. The role will predominantly be a home-based role, but from time to time you may be expected to work from their site Surrey.
The primary responsibilities of this role will revolve around providing preclinical subject matter expertise to support medical writing activities for product lifecycle management and regulatory submissions for consumer health portfolio.
- 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).
- Lead the scientific review nonclinical pharmacology aspects of draft modules prepared by medical writing CROs for accuracy, consistency and quality (specifically 2.4 and 2.6.1-2.6.5).
- 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 our client and preferred medical writing vendors on assigned projects.
- Coordinate key meetings with medical writing vendor.
- 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.
For a confidential and informal chat about the role, contact Helen Tomlinson at CY Partners on 07851246847 or apply online with an up-to-date version of your CV.