Manager, Medical Writing, Immunology

Johnson & Johnson•Spring House, PA

1d•Onsite

About The Position

At Johnson & Johnson, we believe health is everything, leveraging healthcare innovation to prevent, treat, and cure complex diseases with smarter, less invasive, and personal solutions. Through expertise in Innovative Medicine and MedTech, the company aims to deliver breakthroughs that profoundly impact health for humanity. Johnson & Johnson fosters an inclusive work environment, respecting diversity and dignity. The Innovative Medicine sector is driven by patient insights to develop life-saving medicines. The Immunology team specifically focuses on developing transformational medicines for immunological disorders, aiming to restore health to millions. This role, Manager, Medical Writing, Immunology, is part of the Integrated Data Analytics & Reporting (IDAR) Regulatory Medical Writing team and will support the Immunology therapeutic area. The position is available across multiple countries, with remote work options considered on a case-by-case basis.

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 cross‐functional 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.
Primary point of contact and champion for medical writing activities for the clinical team (if a lead writer for a program).
Responsible for planning and leading the writing group for assigned program (if a lead writer for a 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 goal‐setting, 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 (48 hours for Colorado residents, 56 hours for Washington residents)
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