Manager, Medical Writing, Immunology

Johnson & Johnson Innovative Medicine•Spring House, PA

10d•$117,000 - $201,250

About The Position

Johnson & Johnson is seeking a Manager, Medical Writing, Immunology, within Integrated Data Analytics & Reporting (IDAR), supporting the Immunology therapeutic area. The role is part of the Regulatory Medical Writing team and may be based in the United States, Belgium, the Netherlands, Switzerland, the United Kingdom, or Canada. Remote work may be considered case by case and requires Company approval. The Manager prepares and finalizes clinical documents and takes a leading role on assigned projects, contributing to content and scientific strategy as well as schedules and tracking. The position may include leading writing teams for projects, submissions, or indications; serving as the primary medical writing contact for a program; guiding cross-functional colleagues; and improving departmental processes. The Manager also mentors and may oversee other writers and external support, participates in cross-functional and industry groups, and manages direct reports, including hiring, onboarding, development, goal setting, and performance discussions.

Requirements

University or college degree.
At least 8 years of relevant pharmaceutical or scientific experience.
At least 6 years of relevant medical writing experience.
Attention to detail.
Excellent oral and written communication skills for cross-functional discussions.
Expert project and time management skills.
Strong project and process leadership skills.
Ability to interpret, summarize, and present statistical and medical information to ensure content quality and accuracy.
Ability to resolve complex problems independently.
Learning agility.
Ability to build and maintain positive relationships with cross-functional team members.
Solid knowledge and application of regulatory guidance documents, such as ICH requirements.

Nice To Haves

Master's degree or PhD.
2 years of people management experience.

Responsibilities

Prepare and finalize all types of clinical documents.
Lead assigned projects with independence, covering content and scientific strategy, timing, scheduling, and tracking.
Lead or set objectives for others on team projects and tasks, including 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 recommend departmental process improvements.
When serving as lead writer for a program, act as the primary point of contact and champion for medical writing activities, and plan and lead the writing group.
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, and provide peer review as needed.
May oversee 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 in industry standards working groups.
Manage direct reports, set objectives, and meet regularly with them to support development and assignments and resolve issues.
Make hiring decisions; onboard staff; conduct career and talent development discussions; and lead goal-setting and performance discussions.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Eligibility to participate in the Company's long-term incentive program.
Vacation: 120 hours per calendar year, subject to applicable policy and hire date.
Sick time: 40 hours per calendar year, with different amounts for certain state 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 a child's birth, adoption, or foster care placement.
Bereavement Leave: 240 hours for an immediate family member and 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.