Overview
Senior Manager/Associate Director, Regulatory Medical Writing X-TA at Johnson & Johnson Innovative Medicine.
Hybrid (3 days per week onsite) is strongly preferred. Remote work options may be considered on a case-by-case basis and if approved by the company.
The position can be located at any of the following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland) or Spring House/Raritan/Titusville (East Coast US).
Why Join
Join a team focused on developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. This role supports one or more therapeutic areas within the X-TA (Cross Therapeutic Area) Regulatory Medical Writing area.
You Will Be Responsible For
* Leading compound/submission/indication/disease area writing teams independently.
* Possibly holding additional major responsibilities with supervision.
* Working cross-functionally within the organization (cross-TA and cross-J&J initiatives).
* Managing program-level/submission writing teams independently.
* Preparing and finalizing clinical documents with content and scientific strategy leadership, including timing, scheduling, and tracking.
* Guiding or training cross-functional team members on processes, best practices; coaching more junior writers.
* Identifying and championing Medical Writing process improvements, internal standards, regulatory and publishing guidelines, systems, tools, and processes.
* Leading large process improvement initiatives or cross-TA, cross-J&J working groups.
* Developing and disseminating knowledge of industry, company, and regulatory guidelines.
* If leading a program: being the primary point of contact and planning the writing group for the assigned program, and serving as lead writer independently when needed.
* Leading discussions in Medical Writing and cross-functional meetings; coordinating with senior cross-functional colleagues and external partners; overseeing external contractors when applicable.
* As a people manager: managing direct reports in Medical Writing; setting objectives; supporting development and performance; ensuring adherence to policies and templates; involvement in hiring and onboarding.
Qualifications / Requirements
* University/college degree in a scientific discipline is required. Masters or PhD preferred.
* At least 10 years of relevant pharmaceutical/scientific experience; at least 8 years of Medical Writing experience required.
* At least 2 years of people management experience.
* Multiple therapeutic area experience preferred.
* Strong attention to detail; excellent written and spoken English.
* Expert project management and process-improvement leadership.
* Strong leadership skills (influencing, negotiating, initiative, change management) and ability to delegate to junior writers.
* Ability to collaborate with key partners and present complex information accurately.
* Ability to interpret, summarize, and present statistical and medical information for complex document types independently.
Requisitions & Locations
Role may be posted under different requisition numbers to comply with local requirements. Choose country location as applicable:
* United Kingdom - Requisition R-027208
* Belgium, Netherlands - Requisition R-028681
* Switzerland - Requisition R-028682
* United States - Requisition R-028683
Applications across postings are treated as a single submission.
Compensation & Benefits (US)
The anticipated base pay range for this position is $137,000 to $235,750 (USD). Eligible for annual performance bonus and various company-sponsored benefits including medical, dental, vision, life insurance, disability, retirement plans, and paid time off.
Equal Opportunity
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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