Principal Medical Writer

**Site Name**: Bengaluru Luxor North Tower
**Posted Date**: May 12 2025
**Years of Experience: 9 to 12 years**

**Skill Set / Exposure: PV background, DSUR, PBRER, Addendum to CO, PADER/PAER and Risk Management Plans.**
- The Principal Medical Writer is an individual expert contributor capable of independently executing complex writing assignments involving a thorough understanding of safety documents (e.g., aggregate reports and Risk Management Plans [RMPs]) and interpretation of safety data.
- They must demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues.
- This role requires extensive safety document expertise and will support continuous improvement and the implementation of best practices and adoption of new tools and technology.

**Key Responsibilities**:

- Independently lead preparation of complex clinical and post-market safety documents, including but not limited to Development Safety Update Reports (DSURs), Periodic Safety Update Reports/Periodic Benefit-Risk Evaluation Reports (PSURs/PBRERs), Addendums to Clinical Overviews (ACOs), US Periodic Adverse Drug Experience Reports/Periodic Adverse Experience Reports (PADERs/PAERs), RMPs and responses to regulatory authority questions.
- Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions.
- Lead cross-functional teams in document preparation including but not limited to development of content strategy, coordination of content contributions, organization of review schedules, and project timelines.
- Work in a matrix team to ensure delivery of high-quality, fit-for-purpose documents that reflect accurate interpretation of associated safety, clinical, and statistical data, and are in line with GSK standards and global, regional, and/or local regulatory requirements.
- Understand the interdependencies of various contributing functions (e.g., safety, regulatory, clinical, epidemiology, statistics, and programming).
- Anticipate and evaluate complex situations and problems, resolving them by leveraging scientific and operational knowledge in collaboration with stakeholders.
- Assess trends and patterns in text and statistical data and effectively organize content and messages in safety documents.
- Use approaches to expedite document preparation, including authoring and reviewing tools, as well as other automation/technology platforms.
- Serve as a mentor for less experienced writers.
- Develop and deliver training on medical writing topics.
- Lead initiatives to improve medical writing processes.
- Contribute to vendor oversight as needed.

**Education Requirements**:

- Master’s degree or equivalent in a scientific discipline.
- A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in a hospital-based environment, would be an advantage.

**Job Related Experience**:

- Minimum of 7 years of advanced safety writing experience in the pharmaceutical domain including summarization and interpretation of complex data and preparation of complex documents.

**In depth working knowledge of**:

- Relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA) pertaining to clinical trial conduct, pharmacovigilance, and document-specific requirements.
- Core cross-functional clinical research roles and procedures, and how they relate to document strategy and operational preparation.
- Experience in multiple therapeutic areas to have confidence to dive into these areas without lead time.

**Other Job-Related Skills**:

- Advanced safety writing skills with expertise in most safety document types.
- Highly collaborative, capable of leading cross‐functional team members, negotiating solutions, and advising them on document structure and content as needed.
- Skilled in navigating multicultural settings, ensuring effective collaboration with diverse customers and clients, such as health authorities and patients, while adeptly collaborating with remote teams.
- Able to independently lead multiple projects simultaneously and deliver multiple high-quality documents on schedule.
- Advanced computer skills and general computer literacy.
- Excellent English language proficiency, both verbal and written.

**Inclusion at GSK**:

- As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune syste