Job
Description
Job Description: As the Director of Safety Writing at GSK, you will be leading the safety writing team to ensure the accurate, clear, and compliant preparation of Aggregate Reports and Risk Management Plans. Your role will involve a deep understanding of regulatory guidelines, effective leadership skills, and the ability to build a best-in-class capability to achieve organizational business goals related to safety writing. You will oversee the efficient preparation of high-quality safety writing deliverables that are strategically aligned and lead a global team of medical writers. Additionally, you will be responsible for optimizing internal and external resourcing, ensuring compliance, implementing best practices, fostering innovation, streamlining processes, and upholding standards of medical writing. Collaboration with the Head of Medical Writing to develop and drive departmental strategies will also be a key aspect of your role. Your leadership will be instrumental in aligning safety writing capabilities with business and operational needs, working closely with cross-functional safety teams for project clarity, and delivering high-quality safety documents that meet regulatory standards. Key Responsibilities: - Take accountability for all safety writing deliverables produced by the Medical Writing function. - Lead change initiatives to operate at the forefront of operational excellence. - Manage and lead line reports, including aspects of personnel management such as hiring, training, professional development, performance evaluations, compensation recommendations, promotions, teambuilding, and supervision of adherence to departmental procedures and health authority regulations. - Define and execute recruitment strategies to attract top talent. - Incorporate organizational considerations into strategic and operational decisions. - Create a compelling future vision and ensure it is measurable and aligned with organizational goals. - Demonstrate a track record of quality decision making and innovative problem resolution with significant operational impact. - Lead initiatives for process improvement, training, quality enhancement, and compliance. - Act as an industry thought leader, providing consultancy in areas like process improvement, pharmaceutical standardization, and implementation of regulatory guidelines. - Cultivate beneficial partnerships with external organizations to meet company objectives. - Oversee the identification and engagement of third-party partners, ensuring their performance and compliance meet business requirements. Basic Qualifications and Experience: - Minimum requirement of 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 with patient exposure in a hospital-based setting is advantageous. - A total of 18+ years of experience, with at least 10 years in safety writing within the pharmaceutical industry or a large Contract Research Organization, demonstrating leadership skills. Ideal candidates will have expertise in applying FDA, EU, and ICH guidelines for pharmacovigilance in clinical trials and post-marketing, serving as an internal and external safety writing expert. - Experience working in matrix/multicultural environments and diverse settings, especially within hybrid teams. - Strong negotiation skills for proposing creative solutions to new challenges. - Strategic acumen with robust planning and organizational capabilities. - Proficiency in both written and spoken English. - Ability to mentor and discern essential information, ensure logical flow, clarity, accuracy, and appropriateness for target audiences, such as regulatory authorities. Inclusion at GSK: At GSK, we are committed to inclusion and encourage candidates to reach out if they require any adjustments during the recruitment process. Contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs. Why GSK: GSK is a global biopharma company focused on uniting science, technology, and talent to combat disease collectively. Our mission is to positively impact the health of billions of people and deliver sustainable shareholder returns. We value our people as the cornerstone of our success, striving to create an environment where individuals can thrive, grow, and contribute to our shared ambition of getting ahead of disease together. Important Notice to Employment Businesses/Agencies: GSK does not accept referrals from employment businesses/agencies concerning vacancies posted on this site without prior written authorization. It is essential for employment businesses/agencies to contact GSK's commercial and general procurement/human resources department for authorization before referring any candidates. Unauthorized actions by employment businesses/agencies will not be recognized as having consent or contractual agreement with GSK, and GSK will not be liable for any fees arising from such actions. If you receive unsolicited emails or job advertisements from email addresses not ending in gsk.com, please disregard them and notify us at askus@gsk.com for verification of the job's legitimacy.,
