Director, Medical Writing Asset Lead

GSK

Medical Writing Asset Lead Director at GSK designing clinical documents for regulatory submissions, leading teams, and driving process improvements.

Posted 6/13/2026full-timeBengaluru • 🇮🇳 IndiaSenior💰 €81,750 - €136,250 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Providing 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
Leading matrix teams in planning and production of multiple clinical documents, working with CROs and/or independent contractors as needed
Planning and successfully delivering large submissions independently, effectively recommending innovative methods and solutions for achieving accelerated timelines
Assessing and adapting to interdependences of various contributing functions and managing problems affecting timelines as necessary
Ensuring a global approach for submissions as appropriate, collaborating with Global Regulatory Affairs to ensure business needs and regulatory requirements are met
Providing guidance and facilitation to submission teams in development of detailed submission plans
Acting as lead author on submissions
Effectively organizing content and arguments in complex clinical submission documents, including briefing documents and responses to regulatory questions
Proposing resourcing solutions for major projects including the number of FTEs required and best use of internal and external resources
Actively contributing to development of training materials for therapeutic area and providing mentoring and/or training on regulatory requirements, medical writing processes, and submission planning to individuals or teams
Driving, promoting and implementing key organizational process improvement initiatives
Proactively generating ideas for simplification and improvement taking advantage of opportunities that arise and challenging the status quo
Prioritizing and meeting multiple deadlines successfully with attention to detail, demonstrating high performance standards for own work and encouraging similar standards across the matrix
Promoting leadership behaviors that support GSK values.

Requirements

What you’ll need

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.

Benefits

Comp & perks

annual bonus
eligibility to participate in share based long term incentive program

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical regulatory writingclinical study protocolsclinical sections of IMPD/INDInvestigator’s Brochuresclinical study reportsCommon Technical Document SummariesClinical Overviewssubmission planningproject managementmedical writing processes

Soft Skills

leadershipcommunicationstrategic thinkingcritical thinkingproblem solvinginfluencingdecision-makingattention to detailorganizational skillsmentoring

Certifications

PhDPharmDMScMPH