Overview
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at jnj.com/innovative-medicine
About Immunology
Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by 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.
Learn more at jnj.com/innovative-medicine
Role and Location
We are searching for the best talent for Manager, Medical Writing, Immunology. This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any postings, focus on the country(s) that align with your preferred location(s):
United States — Requisition Number: R-069186
Belgium & Netherlands — Requisition Number: R-071183
United Kingdom — Requisition Number: R-071197
Switzerland — Requisition Number: R-071194
Canada — Requisition Number: R-071189
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. 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.
You will be responsible
* Prepare and finalize all types of clinical documents.
* Lead in a team environment. Work with a high level of independence and take 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, 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.
* If a lead writer for a program: Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning and leading the writing group for 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 performance discussions.
Qualifications / Requirements
Education:
Minimum of University/college degree required. Masters 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 are pivotal to engage in cross-functional discussions.
* Expert project/time management skills.
* Strong project/process leadership skills.
* Ability to interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content.
* Able to resolve complex problems independently.
* Demonstrate learning agility.
* Able to build and maintain solid and positive relationships with cross-functional team members.
* Solid knowledge and application of regulatory guidance documents such as ICH requirements.
Required Skills
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
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