Manager, Medical Writing, Immunology

Johnson & Johnson Innovative Medicine•Toronto, ON

2d•CA$134,000 - CA$184,000•Hybrid

About The Position

The Manager, Regulatory Medical Writing, Immunology position is within the Integrated Data Analytics & Reporting (IDAR) team, supporting the Immunology therapeutic area. This role involves preparing and finalizing various clinical documents, leading teams, and contributing to process improvements. The position requires a high level of independence and leadership in managing medical writing activities for assigned projects and programs. The role also includes people management responsibilities, such as setting objectives, conducting performance discussions, and supporting career development for direct reports. The company emphasizes a patient-centric approach and innovation in developing treatments for immunological disorders.

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.
2 years of people management experience.
Attention to detail.
Excellent oral and written communication skills.
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 with a high level of independence on assigned projects regarding content, scientific strategy, timing, scheduling, and tracking.
Set objectives for others on team projects and tasks, such as leading 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.
Serve as the primary point of contact and champion for medical writing activities for the clinical team if a lead writer for a program.
Plan and lead the writing group for assigned programs.
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 the Medical Writing department in industry standards working groups.
Manage direct reports in Medical Writing, setting objectives for individual team members and holding regular meetings to ensure development, project assignments, and issue resolution.
Make decisions on hiring staff, onboarding new staff, conducting career and talent development discussions, leading goal-setting, and performance discussions.