Manager, Medical Writing, Immunology
About The Position
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. 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. 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. 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.
Requirements
- Minimum of University/college degree required.
- 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 recognize how to best 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 crossfunctional team members.
- Solid knowledge and application of regulatory guidance documents such as ICH requirements.
Nice To Haves
- Masters or PhD preferred.
- 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
Responsibilities
- 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, eg, 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 decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goalsetting, and performance discussions.
Benefits
- Annual performance bonus
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short and long-term disability insurance
- Business accident insurance
- Group legal insurance
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Long-term incentive program
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Manager
Number of Employees
5,001-10,000 employees
