Manager, Medical Writing, Immunology

Johnson & Johnson Innovative Medicine • Spring House, PA

3d • $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 Manager will also lead or set objectives for others on team projects and tasks, guide or train cross-functional team members on processes and best practices, and proactively provide recommendations for departmental process improvements. If acting as a lead writer for a program, the individual will be the primary point of contact and champion for medical writing activities for the clinical team, responsible for planning and leading the writing group. The role requires active participation in medical writing and cross-functional meetings, maintaining knowledge of industry, company, and regulatory guidelines, and coaching or mentoring junior staff. The Manager may also interact with senior cross-functional colleagues and represent the Medical Writing department in industry standards working groups. A key responsibility is managing direct reports in Medical Writing, including setting objectives, conducting regular meetings, making hiring decisions, onboarding, conducting career and talent development discussions, leading goal-setting, 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.
• 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.
• 2 years of people management experience is 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

• 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree