Associate Director Medical Writing

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).