Business Introduction At GSK we have bold ambitions for patients aiming to positively impact the health of 2 5 billion people by the end of the decade Our R D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform people s lives GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success We re uniting science technology and talent to get ahead of disease together Find out more Our approach to R D Job Purpose The Associate Director Safety Writing is responsible for leading the safety writing team and ensuring accurate clear and compliant preparation of Aggregate Reports and Risk Management Plans RMP They will provide essential oversight and input into all aspects of aggregate reports and RMP preparation They will participate in process improvements and foster an environment for idea generation Key Responsibilities suggested no more than 10 bullet points Manage a team of 8-10 in-house medical writers to develop aggregate reports and RMPs in scope to support delivery of the portfolio Identify needs for development and for team members to expand their competence and capability in generating documents and working effectively with colleagues in the central teams Set annual objectives to meet writers capabilities development potential and business needs People Management Development Ensure medical writers are trained in relevant procedures policies and standards to be applied for safety writing activities Lead development of training materials for safety documents and provide mentoring coaching and or training to individuals or teams Promote best writing practices and build capability ICH GCP GVP standards process development application and alignment Evaluate resources required for safety writing activities to ensure alignment with the organizations strategic and operational objectives Setting priorities and resource management Provide project updates to leadership and assess forecasting and resourcing Propose creative solutions for shifting timelines and staffing requirements Interface with the cross-functional safety teams and third parties as required to ensure appropriate input and alignment with stakeholders for the resourcing and generation of safety reports in scope On-time delivery with quality Drive and implement key organizational process improvement initiatives Proactively generate ideas for improvement and promote an empowering environment for others to generate ideas e g for accelerated simplified processes champion improvements in technology and ways of working Provide leadership and strategic planning adjustments delegation of responsibilities and tasks Monitor progress of each individual project task and assess the overall project performance In collaboration with the MW leadership team and the Safety leadership team measure and monitor efficiency and quality of the team s output collect and evaluate metrics to identify the need for improvement in processes staff educational activities etc Education Requirements minimum expected 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 Job Related Experience minimum requirements 6-8 years experience in safety writing including leading the development of safety reports in a post-market setting within the pharmaceutical Contract Research Organization industry Other Job-Related Skills Demonstrate experience in 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 Demonstrate leadership skills and the ability to identify and evaluate viable options to make decisions in a timely and effective manner Ability to plan work to meet deadlines and effectively handle multiple priorities Ability to understand medical-scientific data from a broad range of therapeutic areas Strategic skills with strong planning and organizational skills Exhibits the ability to analyze complex issues using data logic and judgment to identify problems determine root cause and recommend solutions to resolve and prevent issues 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 Business Introduction At GSK we have bold ambitions for patients aiming to positively impact the health of 2 5 billion people by the end of the decade Our R D focuses on discovering and delivering vaccines and medicines combining our understanding of the immune system with cutting-edge technology to transform people s lives GSK fosters a culture ambitious for patients accountable for impact and committed to doing the right thing making sure that we focus our efforts on accelerating significant assets that meet patients needs and have the highest probability of success We re uniting science technology and talent to get ahead of disease together Find out more Our approach to R D Job Purpose The Associate Director Safety Writing is responsible for leading the safety writing team and ensuring accurate clear and compliant preparation of Aggregate Reports and Risk Management Plans RMP They will provide essential oversight and input into all aspects of aggregate reports and RMP preparation They will participate in process improvements and foster an environment for idea generation Key Responsibilities suggested no more than 10 bullet points Manage a team of 8-10 in-house medical writers to develop aggregate reports and RMPs in scope to support delivery of the portfolio Identify needs for development and for team members to expand their competence and capability in generating documents and working effectively with colleagues in the central teams Set annual objectives to meet writers capabilities development potential and business needs People Management Development Ensure medical writers are trained in relevant procedures policies and standards to be applied for safety writing activities Lead development of training materials for safety documents and provide mentoring coaching and or training to individuals or teams Promote best writing practices and build capability ICH GCP GVP standards process development application and alignment Evaluate resources required for safety writing activities to ensure alignment with the organizations strategic and operational objectives Setting priorities and resource management Provide project updates to leadership and assess forecasting and resourcing Propose creative solutions for shifting timelines and staffing requirements Interface with the cross-functional safety teams and third parties as required to ensure appropriate input and alignment with stakeholders for the resourcing and generation of safety reports in scope On-time delivery with quality Drive and implement key organizational process improvement initiatives Proactively generate ideas for improvement and promote an empowering environment for others to generate ideas e g for accelerated simplified processes champion improvements in technology and ways of working Provide leadership and strategic planning adjustments delegation of responsibilities and tasks Monitor progress of each individual project task and assess the overall project performance In collaboration with the MW leadership team and the Safety leadership team measure and monitor efficiency and quality of the team s output collect and evaluate metrics to identify the need for improvement in processes staff educational activities etc Education Requirements minimum expected 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 Job Related Experience minimum requirements 6-8 years experience in safety writing including leading the development of safety reports in a post-market setting within the pharmaceutical Contract Research Organization industry Other Job-Related Skills Demonstrate experience in 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 Demonstrate leadership skills and the ability to identify and evaluate viable options to make decisions in a timely and effective manner Ability to plan work to meet deadlines and effectively handle multiple priorities Ability to understand medical-scientific data from a broad range of therapeutic areas Strategic skills with strong planning and organizational skills Exhibits the ability to analyze complex issues using data logic and judgment to identify problems determine root cause and recommend solutions to resolve and prevent issues 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 Why GSK Uniting science technology and talent to get ahead of disease together GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together We aim to positively impact the health of 2 5 billion people by the end of the decade as a successful growing company where people can thrive We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines We focus on four therapeutic areas respiratory immunology and inflammation oncology HIV and infectious diseases - to impact health at scale People and patients around the world count on the medicines and vaccines we make so we re committed to creating an environment where our people can thrive and focus on what matters most Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people 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 Significant notice to Employment businesses Agencies GSK does not accept referrals from employment businesses and or employment agencies in respect of the vacancies posted on this site All employment businesses agencies are required to contact GSK s commercial and general procurement human resources department to obtain prior written authorization before referring any candidates to GSK The obtaining of prior written authorization is a condition precedent to any agreement verbal or written between the employment business agency and GSK In the absence of such written authorization being obtained any actions undertaken by the employment business agency shall be deemed to have been performed without the consent or contractual agreement of GSK GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses agencies in respect of the vacancies posted on this site It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection 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📌 Associate Director Medical Writing (Karnataka)
🏢 GSK
📍 Karnataka