Director Medical Writing Job at GSK
A senior opportunity awaits professionals looking for a Medical Writing Job at GSK in Bengaluru. The Director Medical Writing Asset Lead role offers experienced scientific professionals the chance to shape clinical document strategies, lead regulatory submissions, and influence drug development programs. For candidates exploring GSK Careers and senior Medical Jobs India, this hybrid position provides an opportunity to combine scientific expertise, strategic leadership, medical writing, and pharmaceutical development.
About GSK:
GSK is a global biopharma company focused on combining science, technology, and talent to develop innovative medicines and vaccines. The organisation works across multiple therapeutic areas with a strong focus on improving patient outcomes. GSK promotes an environment built around scientific excellence, accountability, collaboration, and innovation. For professionals exploring GSK Careers, the company offers opportunities to contribute to significant drug development programs while building expertise in areas such as clinical development and medical writing.
Job Details:
- Position: Director Medical Writing Asset Lead
- Location: Bengaluru, India
- Category: Medical and Clinical
- Job ID: 446143
- Employment Type: Full-time
- Work Model: Hybrid – Remote & On-site
Job Description:
The Director Medical Writing Asset Lead at GSK is tasked with applying scientific and operational expertise to provide a comprehensive medical writing and submissions strategy for key assets, particularly in Hepatology. This role involves designing and delivering high-quality clinical documents for global regulatory submissions, ensuring efficient workflows, and contributing to organisational process improvements. This position is highly visible and offers the opportunity to lead significant activities that can advance a career in medical writing.
Key Responsibilities:
- Contributing to clinical document strategy for drug development, including clinical study protocols and regulatory submissions.
- Leading matrix teams to produce multiple clinical documents, collaborating with CROs and independent contractors as needed.
- Planning and delivering large submissions independently, while managing timelines and ensuring compliance with global regulatory requirements.
- Acting as lead author on complex clinical submission documents and responses to regulatory questions.
- Proposing resource solutions for major projects, including FTE requirements and resource allocation.
- Developing training materials and mentoring teams on regulatory requirements and medical writing processes.
- Driving organisational process improvement initiatives and promoting the adoption of technology in medical writing.
- Prioritising multiple deadlines with attention to detail and high performance standards.
Eligibility Criteria for this Medical Writing Job:
Professionals applying for this role should possess the following qualifications:
- PharmD, MPH or other post-graduate degree.
- Substantial experience in clinical regulatory writing and submissions in the pharmaceutical industry.
- Strong project management and communication skills, with demonstrated matrix leadership.
Required Skills for this Medical Writing Job:
- Clinical Development
- Medical Writing
- Regulatory Submissions
- Strategic Thinking
- Communication Skills
- Project Management
- Scientific Writing
- Decision Making
