Manager, Medical Writing, Immunology
Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting for a Manager, Regulatory Medical, Immunology. This position will support our Immunology therapeutic area.
Purpose
Prepare and finalize all types of clinical documents; lead in a team environment with a high level of independence; guide and train cross‑functional team members; lead or set objectives for others on team projects; proactively provide recommendations for departmental process improvements; act as the primary point of contact for medical writing activities for the clinical team; maintain knowledge of industry, company, and regulatory guidelines; coach or mentor junior staff; manage direct reports; and make decisions on hiring, onboarding, and performance discussions.
Responsibilities
- Prepare and finalize all types of clinical documents.
- Lead in a team environment; work independently and take the lead on assigned projects regarding content, scientific strategy, timing, scheduling, and tracking.
- Lead or set objectives for others on team projects and tasks, e.g., lead process working groups.
- Guide or train cross‑functional team members on processes and best practices.
- May lead project‑level/submission/indication writing teams.
- Proactively provide recommendations for departmental process improvements.
- As the lead writer for a program: serve as the primary point of contact and champion for medical writing activities for the clinical team, planning and leading the writing group for the assigned program.
- Actively participate in medical writing and cross‑functional meetings.
- Maintain knowledge of industry, company, and regulatory guidelines.
- Coach or mentor more junior staff on document planning, processes, content, and provide peer review as needed; may oversee the work of other medical writers, external contractors, and document specialists supporting a project.
- May interact with senior cross‑functional colleagues to strengthen coordination between departments.
- May represent Medical Writing department in industry standards working groups.
- Manage direct reports in Medical Writing; set objectives for individual team members; regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
- Make decisions on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal‑setting, and conduct performance discussions.
Qualifications
Education
Minimum of a University/College degree required; a Master’s or PhD preferred.
Experience and Skills
- At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience is required.
- 2 years of people management experience is required.
- Attention to detail.
- Excellent oral and written communication skills pivotal for cross‑functional discussions.
- Expert project/time management skills.
- Strong project/process leadership skills.
- Ability to interpret, summarize, and present statistical and medical information accurately.
- Able to resolve complex problems independently.
- Demonstrate learning agility.
- Ability to build and maintain solid, positive relationships with cross‑functional team members.
- Solid knowledge and application of regulatory guidance documents such as ICH requirements.
Required Skills
- Analytics Insights
- Business Writing
- Clinical Research and Regulations
- Clinical Trials Operations
- Copy Editing
- Cross‑Functional Collaboration
- Developing Others
- Inclusive Leadership
- Industry Analysis
- Leadership
- Medical Affairs
- Medical Communications
- Performance Measurement
- Quality Validation
- Standard Operating Procedure (SOP)
- Tactical Planning
- Team Management
Preferred Skills
- Analytics Insights
- Business Writing
- Clinical Research and Regulations
- Clinical Trials Operations
- Copy Editing
- Cross‑Functional Collaboration
- Developing Others
- Inclusive Leadership
- Industry Analysis
- Leadership
- Medical Affairs
- Medical Communications
- Performance Measurement
- Quality Validation
- Standard Operating Procedure (SOP)
- Tactical Planning
- Team Management
