Restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
We are searching for the best talent for Manager, Medical Writing, Immunology.
Locations & Requisition Numbers
* United States – R-069186
* Belgium & Netherlands – R-071183
* United Kingdom – R-071197
* Switzerland – R-071194
* Canada – R-071189
Remote work options may be considered on a case‑by‑case basis and if approved by the Company.
Purpose
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.
Responsibilities
* Prepare and finalize all types of clinical documents.
* Lead in a team environment, working with a high level of independence 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, including leading process working groups.
* Guide or train cross‑functional team members on processes and best practices.
* May lead project‑level, submission, or indication writing teams.
* Proactively provide recommendations for departmental process improvements.
* Act as the primary point of contact and champion for medical writing activities for the clinical team; plan and lead the writing group for assigned programs.
* Actively participate in medical writing and cross‑functional meetings.
* Maintain knowledge of industry, company, and regulatory guidelines.
* Coach or mentor junior staff on document planning, processes, and content; provide peer reviews and may oversee the work of other medical writers, external contractors, and document specialists.
* Interact with senior cross‑functional colleagues to strengthen coordination between departments.
* Represent the Medical Writing department in industry standards working groups.
* Manage direct reports, set objectives, and regularly meet to ensure appropriate development, project assignments, and issue resolution.
* Make decisions on hiring, onboarding, and conducting career and talent development discussions; lead goal‑setting and performance discussions.
Qualifications & Requirements
* Education: Minimum of a University/College degree required. Masters or PhD preferred.
* Experience: At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of medical writing experience; at least 2 years of people‑management experience.
* Key Skills: Attention to detail; excellent oral and written communication; expert project/time management; strong project/process leadership; ability to interpret, summarize, and present statistical and medical information accurately; independent problem solving; learning agility; relationship building with cross‑functional team members; solid knowledge of regulatory guidance documents such as ICH requirements.
* 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.
#J-18808-Ljbffr