Associate Director Medical Writing

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- to discuss your needs.

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