Manager, Medical Writing, Immunology

6010-Biosense Webster Inc. Legal Entity; Toronto; On-site; CAD 191,000 - 262,000; Full time

Benefits offered by this job

Performance bonus eligibility

Job summary

Johnson & Johnson is seeking a Manager for Regulatory Medical Writing in Immunology to lead document planning, writing, and cross-functional collaboration. The role requires guiding teams on content, strategy, and timelines, with mentorship and process improvements across programs.

You will oversee submitting documents, coordinate with clinical teams, and ensure adherence to industry guidelines while driving high-quality scientific communications for Innovative Medicine at J&J.

Qualifications

• Minimum of University/college degree required.
• Masters or PhD preferred.

Responsibilities

• Prepare and finalize all types of clinical documents.
• Lead in a team environment and manage project content and timing.
• Coach or mentor junior staff on document planning and processes.
• May lead project-level submission writing teams and interact with cross-functional colleagues.

Skills

Attention to detail

Outstanding written/oral communication

Project/time management

Leadership

Regulatory guidance knowledge (ICH)

Education

University/college degree

Masters or PhD preferred

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Medical Affairs Group

Job Sub Function: Medical Writing

Job Category: People Leader

All Job Posting Locations: Toronto, Ontario, Canada

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

About Immunology

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine

Purpose: Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting for a Manager, Regulatory Medical, Immunology.

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.

Qualifications/Requirements:

Education:

Minimum of University/college degree required. Masters or PhD preferred.

Experience and Skills:

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 preferred. Attention to detail.

Required Skills:

• 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.

Preferred Skills:

• 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

The anticipated base pay range for this position is : $134,000 - $184,000 Additional Description for Pay Transparency: Under current guidelines, this position is eligible for a discretionary performance bonus.

The Company uses Artificial Intelligence in its assessment of applicants.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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