Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

This position supports the Immunology therapeutic area within the Integrated Data Analytics & Reporting (IDAR) Regulatory Medical Writing team. The role involves preparing and finalizing clinical documents, leading teams, and managing direct reports.

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.
• 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.
• Act as the primary point of contact and champion for medical writing activities for the clinical team.
• Plan and lead 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, and content.
• 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 decisions on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in 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.

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

Location

• Toronto, Ontario, Canada

Work Type

• Remote work options may be considered on a case-by-case basis

Experience Level

• 8 years of relevant pharmaceutical/scientific experience
• 6 years of relevant medical writing experience
• 2 years of people management experience

Education Level

• University/college degree
• Masters or PhD preferred

Salary/Compensations

• $134,000-$184,000

Benefits

• Eligible for a discretionary performance bonus

About the Company

• 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/.
• 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

Equal Opportunity

• 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.