- Provide preclinical subject matter expertise to support medical writing activities for product lifecycle management and regulatory submissions for the GSK CH 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.
- 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 GSK CH 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 GSK CH and preferred medical writing vendors on assigned projects.
- Coordinate key meetings with medical writing vendors and GSK CH functional contributors (e.g. regulatory affairs, safety, toxicology etc.) per GSK CH 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.
Key Competencies and Experience
- Minimum BSc (or equivalent) in a relevant scientific field (e.g. biomedical sciences). PhD preferred.
- Significant experience (5 years+) in the Pharmaceutical or Consumer Healthcare industry.
- Minimum 5 years’ experience providing preclinical scientific contributions to regulatory submission documents including nonclinical CTD modules 2.4 and 2.6.x.
- Demonstrated experience working effectively in a complex matrix organization and ability to work as part of a talented, interdisciplinary and diverse team to deliver projects on time and to a high quality.
- Demonstrated scientific competency in understanding the strengths and limitations of preclinical in vitro and in vivo models. Preclinical expertise with medicated pain relief, respiratory and allergy products is preferred.
- Experienced working with external medical writing vendors and clinical research organisations. Familiar with reviewing task orders, providing vendor oversight and reviewing draft and final documents from 3rd parties.
- Collaborative approach, with demonstrated experience representing an organization in interactions with external stakeholders.
- Detail-focussed, with strong analytical, planning and organisational skills and the ability to work on multiple products in parallel and adept at managing conflicting priorities, risks and issues.
- Ability to work remotely from key team members.
- Fluent in English language.
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