Manager, Medical Writing, Immunology

Johnson & Johnson Innovative Medicine

2d•$117,000 - $201,250•Hybrid

About The Position

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. The role involves preparing and finalizing all types of clinical documents, leading in a team environment with a high level of independence, and taking a lead role on assigned projects regarding content, scientific strategy, timing, scheduling, and tracking. The position may also involve leading or setting objectives for others on team projects, guiding cross-functional team members on processes and best practices, and potentially leading project-level/submission/indication writing teams. The role also includes proactively providing recommendations for departmental process improvements, acting as the primary point of contact for medical writing activities for a program if a lead writer, actively participating in medical writing and cross-functional meetings, and maintaining knowledge of industry, company, and regulatory guidelines. Additionally, the role involves coaching and mentoring junior staff, overseeing the work of other medical writers and external contractors, interacting with senior cross-functional colleagues, and potentially representing the Medical Writing department in industry standards working groups. A key aspect of the role is managing direct reports, including setting objectives, conducting regular meetings, making hiring decisions, onboarding new staff, and leading career development and performance discussions.

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.

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 goal‐setting, and performance discussions.

Benefits

Annual performance bonus
Medical insurance
Dental insurance
Vision insurance
Life insurance
Short-term disability insurance
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 (may vary by state)
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