Director Medical Writing Asset Lead
GSK
2 months ago
Remote friendly (Collegeville, PA)
United States
Clinical Research and Development
Position Summary
As Medical Writing Asset Lead Director, you will provide medical writing strategy for one or more assets. You will design and deliver high-quality clinical documents for global regulatory submissions, plan efficient and accelerated ways of working, and contribute to organizational process improvements.
Key Responsibilities
- Provide key contributions to clinical document strategy across the drug development life cycle (e.g., clinical study protocols, IMPD/IND sections, Investigator’s Brochures, clinical study reports, regulatory briefing documents, CTD Summaries and Clinical Overviews, and responses to regulatory authority questions).
- Lead matrix teams for planning and production of multiple clinical documents; partner with CROs and/or independent contractors as needed.
- Independently plan and deliver large submissions; recommend innovative approaches for accelerated timelines; manage interdependencies and timeline risks; collaborate with Global Regulatory Affairs to meet business needs and regulatory requirements; guide submission teams in detailed submission planning.
- Act as lead author on submissions, organizing content and arguments in complex clinical documents, including briefing documents and regulatory responses.
- Propose resourcing solutions for major projects (e.g., number of FTEs and internal/external resource mix).
- Contribute to development of therapeutic area training materials and provide mentoring/training on regulatory requirements, medical writing processes, and submission planning.
- Drive organizational process improvement initiatives; generate and implement ideas to simplify and improve document lifecycle while challenging the status quo.
- Prioritize and meet multiple deadlines with strong attention to detail; encourage high performance standards across the matrix.
- Promote leadership behaviors aligned with GSK values.
Basic Qualifications (Required)
- Postgraduate degree (e.g., PhD, PharmD, MSc, MPH) in life sciences, pharmacy, medicine, public health, or related field.
- Extensive experience in clinical regulatory writing in the pharmaceutical industry with a proven track record of authoring relevant clinical documents.
- Extensive experience in project management, planning, communication, and matrix leadership.
- Strong understanding of clinical operations/medical writing processes and ICH/GCP plus global regulatory guidelines for drug development and approval.
- Strong strategic and critical thinking, problem solving, influencing, and decision-making.
Preferred Qualifications
- Experience delivering accelerated submissions for EU, US, China, Japan, and Rest of World.
- Experience in clinical pharmacology, including PK/PD interpretation.
- Demonstrated cross-functional collaboration and ability to build networks and influence stakeholders at all levels.
As Medical Writing Asset Lead Director, you will provide medical writing strategy for one or more assets. You will design and deliver high-quality clinical documents for global regulatory submissions, plan efficient and accelerated ways of working, and contribute to organizational process improvements.
Key Responsibilities
- Provide key contributions to clinical document strategy across the drug development life cycle (e.g., clinical study protocols, IMPD/IND sections, Investigator’s Brochures, clinical study reports, regulatory briefing documents, CTD Summaries and Clinical Overviews, and responses to regulatory authority questions).
- Lead matrix teams for planning and production of multiple clinical documents; partner with CROs and/or independent contractors as needed.
- Independently plan and deliver large submissions; recommend innovative approaches for accelerated timelines; manage interdependencies and timeline risks; collaborate with Global Regulatory Affairs to meet business needs and regulatory requirements; guide submission teams in detailed submission planning.
- Act as lead author on submissions, organizing content and arguments in complex clinical documents, including briefing documents and regulatory responses.
- Propose resourcing solutions for major projects (e.g., number of FTEs and internal/external resource mix).
- Contribute to development of therapeutic area training materials and provide mentoring/training on regulatory requirements, medical writing processes, and submission planning.
- Drive organizational process improvement initiatives; generate and implement ideas to simplify and improve document lifecycle while challenging the status quo.
- Prioritize and meet multiple deadlines with strong attention to detail; encourage high performance standards across the matrix.
- Promote leadership behaviors aligned with GSK values.
Basic Qualifications (Required)
- Postgraduate degree (e.g., PhD, PharmD, MSc, MPH) in life sciences, pharmacy, medicine, public health, or related field.
- Extensive experience in clinical regulatory writing in the pharmaceutical industry with a proven track record of authoring relevant clinical documents.
- Extensive experience in project management, planning, communication, and matrix leadership.
- Strong understanding of clinical operations/medical writing processes and ICH/GCP plus global regulatory guidelines for drug development and approval.
- Strong strategic and critical thinking, problem solving, influencing, and decision-making.
Preferred Qualifications
- Experience delivering accelerated submissions for EU, US, China, Japan, and Rest of World.
- Experience in clinical pharmacology, including PK/PD interpretation.
- Demonstrated cross-functional collaboration and ability to build networks and influence stakeholders at all levels.