Director - Safety Writing

Be You’ at GSK

At GSK, we unite science, technology, and talent to get ahead of diseases together. 

We are a world leader in infectious diseases, including vaccines and HIV, with the broadest portfolio in the industry, pushing the frontiers of respiratory science and improving the lives of millions of patients, recognised for our ESG leadership, making an impact on some of society’s most urgent challenges We’re confident that together we can make a positive impact on the health of more than 2.5 billion people by 2031.

When you set out on your adventure at GSK, we make a deal. You commit to living our values and performing against our Innovation, Performance and Trust priorities. In return, GSK commits to providing the right environment for you to thrive.  Together, we build an environment where we can all thrive and focus on what matters most to each of us. 

Job Purpose: 

The Director of Safety Writing is responsible for leading the safety writing team and ensuring the accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans. This role requires a thorough understanding of regulatory guidelines, and the ability to apply leadership and build a best-in-class capability to deliver the organizational business goals relevant to safety writing. They are expected to oversee efficient preparation of high quality, strategically aligned safety writing deliverables and lead a global team of medical writers. Lead optimization of internal and external resourcing, compliance, best practices, innovation, effective processes, and standards of medical writing. They will support the Head of Medical Writing in developing, shaping, and driving departmental strategies. They will provide leadership to ensure safety writing capabilities align with business and operational needs, collaborate with cross functional safety teams for project clarity, and ensure delivery of high-quality safety documents that meet regulatory standards.

Key Responsibilities

• Accountable for all safety writing deliverables produced by the Medical Writing function.
• Accountable for leading change to operate at the cutting edge of operational excellence.
• Lead and manage line reports as applicable, including all aspects of personnel management: hiring, training, professional development, periodic/annual performance evaluations, compensation recommendations, promotions, teambuilding, morale motivation, and supervision of adherence to departmental procedures and health authority guidance and regulations. Define and execute strategies for recruitment of top talent.
• Strong understanding and ability to incorporate organizational considerations into strategic and operational decisions.
• Create and inspire commitment to a future vision. Ensure it is measurable and aligned with organizational goals. Lead through vision and values.
• Demonstrated track record of quality decision making and creative problem resolution with significant impact on operations, systems, processes, programs/project direction.
• Lead process improvement, training, quality, and compliance.
• Act as an industry thought leader to provide consultancy in areas such as process improvement/pharma standardization/implementation of regulatory guidelines and updates etc.
• Act as an influential partner, internally and externally, to form beneficial partnerships with external organisations to meet company objectives (e.g., alliance partners, contract research organisation).
• Oversee the identification and engagement of third-party partners, including performance and compliance of our third-party partners. Ensure that third-party partners provide the right capabilities required by the business.

Basic Qualifications and Experience:

• Minimum qualification required would be a master’s degree in life Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.). A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient exposure in a hospital-based environment, would be an advantage.
• Total 18+ years our of which minimum 10 years’ experience in safety writing, experience in the pharmaceutical industry, or large Contract Research Organisation, including demonstration of leadership. The ideal candidate will possess expertise in applying FDA, EU, and ICH guidelines for pharmacovigilance in clinical trials and post-marketing, acting as an internal and external safety writing expert.

• Demonstrate experience working in matrix/multicultural settings and diverse environments particularly with respect to dynamics of working with hybrid teams.

• Highly pragmatic with strong negotiation skills (to propose creative solutions to new challenges)

• Strategic skills with strong planning and organizational skills

• Outstanding knowledge of written and spoken English.

• Ability to mentor and understand selection of essential information, logical flow, clarity, accuracy appropriate for target audiences (e.g., regulatory authorities).

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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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 system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.