Clinical Development Scientist
£75 per hour via umbrella
12 month contract
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.
• A critical part of the role will be to 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 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.
• Minimum 5-10 years experience providing preclinical scientific contributions to regulatory submission documents, specifically nonclinical pharmacology content of ICH-compliant CTD modules 2.4 and 2.6.1-2.6.5.
• Significant experience (5-10 years+) in the Pharmaceutical or Consumer Healthcare industry.
• 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.