Manager, Medical Writing, Immunology

Johnson & Johnson Innovative Medicine•Toronto, ON

1d•CA$134,000 - CA$184,000•Remote

About The Position

The Regulatory Medical Writing team within Integrated Data Analytics & Reporting (IDAR) is seeking a Manager, Regulatory Medical, Immunology to support the Immunology therapeutic area. This role involves preparing and finalizing clinical documents, leading teams with independence, and contributing to scientific strategy, timing, scheduling, and tracking of projects. The position also includes guiding cross-functional team members, recommending process improvements, and potentially leading writing teams for submissions or indications. As a lead writer, the individual will be the primary point of contact for medical writing activities for the clinical team, responsible for planning and leading the writing group for assigned programs. The role requires active participation in meetings, maintaining knowledge of industry and regulatory guidelines, coaching junior staff, and potentially representing Medical Writing in industry standards working groups. A key aspect of this role is managing direct reports, including setting objectives, conducting performance discussions, and making decisions on hiring and onboarding.

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 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, e.g., 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.