Director Medical Writing Asset Lead Job at GSK in collegeville

Site Name:

GSK HQ, Belgium-Wavre, Bengaluru Luxor North Tower, Canada - Ontario - Mississauga, Stevenage, Upper Providence, Warsaw

Business Introduction

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting‑edge technology to transform people’s lives. GSK fosters a culture that is ambitious for patients, accountable for impact, and committed to doing the right thing, ensuring that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We unite science, technology, and talent to get ahead of disease together.

Position Summary

As Medical Writing Asset Lead Director, you will apply experience, scientific and operational expertise, and leadership in a matrix organization to provide the medical writing strategy for one or more assets. You will design and deliver high‑quality, fit‑for‑purpose clinical documents for global regulatory submissions, plan for efficient and accelerated ways of working, and contribute to key organizational process improvements.

Key Responsibilities

• Provide key contributions to clinical document strategy for one or more assets throughout the life cycle of drug development. Documents in scope include, but are not limited to, clinical study protocols, clinical sections of the IMPD/IND, Investigator’s Brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overviews, and responses to regulatory authority questions.
• Lead matrix teams in planning and production of multiple clinical documents, working with CROs and/or independent contractors as needed.
• Plan and successfully deliver large submissions independently, recommending innovative methods and solutions for achieving accelerated timelines, and managing problems affecting timelines as necessary.
• Act as lead author on submissions, effectively organizing content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions.
• Propose resourcing solutions for major projects, including the number of FTEs required and best use of internal and external resources.
• Actively contribute to the development of training materials for the therapeutic area and provide mentoring and/or training on regulatory requirements, medical writing processes, and submission planning to individuals or teams.
• Drive, promote, and implement key organizational process improvement initiatives, proactively generating ideas for simplification and improvement.
• Prioritize and meet multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix.
• Promote leadership behaviors that support GSK values.

Basic Qualifications

• Postgraduate degree (e.g., PhD, PharmD, MSc, MPH) in life sciences, pharmacy, medicine, public health or related discipline.
• Extensive experience in clinical regulatory writing in the pharmaceutical industry, with a proven track record of writing the clinical documents in scope.
• Extensive experience in project management, planning, communication, and demonstrated matrix leadership to deliver results.
• Excellent understanding of clinical operations / medical writing processes, and ICH/GCP and global regulatory guidelines for drug development and approval.
• Strong strategic and critical thinking, problem‑solving, influencing and decision‑making capabilities.

Preferred Qualifications

• Experience in delivering accelerated submissions for EU, US, China, Japan and Rest of World.
• Experience in clinical pharmacology applied to clinical development and pharmacokinetic/pharmacodynamic (PK/PD) interpretation.
• Demonstrated cross‑functional collaboration with effective communication skills and experience in building networks and influencing partners and stakeholders at all levels of the organization.

Equal Opportunity Employer Statement

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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