Manager, Medical Writing, Immunology

Johnson & Johnson Innovative Medicine•Toronto, ON

5d•Remote

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 with respect to content and scientific strategy, timing, scheduling, and tracking. The position also includes leading or setting objectives for others on team projects and tasks, guiding or training cross-functional team members on processes and best practices, and potentially leading project-level/submission/indication writing teams. Proactive recommendations for departmental process improvements are expected. 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, and actively participating in medical writing and cross-functional meetings. Maintaining knowledge of industry, company, and regulatory guidelines, coaching or mentoring junior staff, and potentially overseeing the work of other medical writers, external contractors, and document specialists are key aspects. The role may involve interacting with senior cross-functional colleagues and representing the Medical Writing department in industry standards working groups. Additionally, the Manager will manage direct reports, set objectives, conduct regular meetings for development and issue resolution, and make decisions on hiring, onboarding, career development, 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.
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.
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.