Immunology Regulatory Medical Writing Team Lead
hace 2 semanas
At Johnson & Johnson Innovative Medicine, we are dedicated to helping people live full and healthy lives. Our team focuses on treating, curing, and preventing some of the most devastating and complex diseases of our time.
We discover and develop innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina.
The Regulatory Medical Writing team within Integrated Data Analytics & Reporting (IDAR) is seeking a Manager to support our Immunology therapeutic area.
The position may be located in the UK, other European countries, or India. Remote work options may be considered on a case-by-case basis and if approved by the company.
Key Responsibilities:
- Prepare and finalize all types of clinical documents.
- Lead a team environment, working with a high level of independence and taking a lead role on assigned projects with respect to content and scientific strategy, timing, scheduling, and tracking.
- Lead or set objectives for others on team projects and tasks, such as leading 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.
- 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 the Medical Writing department in industry standards working groups.
- Manage direct reports in Medical Writing, set objectives for individual team members, and regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
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