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About the Role

This role functions as a lead writer for compounds, independently setting functional and project-level strategy. The Associate Director may represent the therapeutic area head at high-level and cross-functional meetings, possessing independent decision-making authority. Responsibilities include writing and coordinating complex documents across therapeutic areas, contributing to and championing internal standards, regulatory, and publishing guidelines, and improving internal systems, tools, and processes. The role leads process working groups, oversees external contractors, and may manage a team of internal medical writers, ensuring quality and compliance of deliverables.

Responsibilities

Lead writing teams for compounds, submissions, indications, or disease areas.
Lead or set objectives for team projects and tasks, including Medical Writing process working groups or Communities of Practice.
Write or coordinate clinical and regulatory documents, leading content and scientific strategy.
Establish and drive document timelines and strategies.
Guide and train cross-functional team members on processes and best practices; coach and mentor junior writers.
Proactively identify and champion departmental process improvements.
Develop and present best practices or innovations to internal or external audiences.
Lead cross-functional, cross-therapeutic area, or cross-Johnson & Johnson process improvement initiatives.
Lead discussions in Medical Writing and cross-functional meetings.
Maintain and disseminate knowledge of industry, company, and regulatory guidelines.
Complete time reporting, training, metrics database, and project tracking updates.
Coach and mentor junior staff on document planning, processes, and content; provide peer review.
Provide guidance on Medical Writing deliverables and content.
Interact with senior cross-functional colleagues and external partners to strengthen departmental coordination.
Represent Medical Writing in industry standards working groups.
Serve as the primary Medical Writing point of contact for cross-functional teams.
Supervise and manage direct reports.
Set objectives and goals for direct reports.
Provide performance oversight, feedback, and development.
Meet regularly with direct reports to ensure development, project assignments, and issue resolution.
Ensure direct reports adhere to established policies, procedures, and templates.
Participate in hiring, onboarding, career development, goal-setting, performance reviews, and compensation planning for staff.

Requirements

Minimum Bachelor's Degree.
Minimum 10 years of relevant pharmaceutical/scientific experience.
Minimum 8 years of relevant clinical/regulatory medical writing experience.
Experience in project management and process improvement.
Minimum 2 years of people management experience.
Ability to interpret, summarize, and present statistical and medical information accurately in complex documents.
Ability to resolve complex problems independently.
Advanced knowledge and application of regulatory guidance documents (e.g., ICH requirements).
Ability to interact with senior cross-functional colleagues and external partners, coordinating across multiple functions.
Proactively identify potential risks and develop mitigation strategies.
Identify and resolve problems related to new service offerings/deliverables.
Ability to serve as a liaison between team members and senior leadership within a Therapeutic Area.

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)
Succession Planning
Tactical Planning
Team Management
Excellent oral and written communication skills
Attention to detail
Expert time management for self, direct reports, and teams
Ability to build and maintain solid and productive relationships with cross-functional team members
Expert project management skills
Expert project/process leadership
Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management)
Ability to delegate responsibility to junior writers
Ability to lead by example, stay focused and positive, and act with integrity
Ability to internalize and teach CREDO behaviors
Ability to act as change agent and adapt to rapidly changing organizational & business challenges
Strong people management skills

Location

Toronto, Ontario, Canada
Remote (case-by-case basis)

Work Type

Remote (case-by-case basis)

Experience Level

Minimum 10 years of relevant pharmaceutical/scientific experience
Minimum 8 years of relevant clinical/regulatory medical writing experience
Minimum 2 years of people management experience

Education Level

Minimum Bachelor's Degree
Advanced degree (Masters, PhD, MD) (preferred)

Salary/Compensations

$139,750-$189,750 (base pay range)
Eligible for discretionary performance bonus

About the Company

Johnson & Johnson believes health is everything, leveraging healthcare innovation to prevent, treat, and cure complex diseases, and deliver smarter, less invasive, personal solutions.
The company innovates across the full spectrum of healthcare solutions through expertise in Innovative Medicine and MedTech, aiming to profoundly impact health for humanity.
Guided by Our Credo, Johnson & Johnson is responsible to employees globally, providing an inclusive work environment that respects diversity, dignity, and merit.
Innovative Medicine expertise is patient-informed, driving science-based advancements to develop future medicines, treatments, and cures.
The Oncology team focuses on eliminating cancer by discovering new pathways and modalities for treatments and cures, leading medical advancements with a commitment to results.

Equal Opportunity

Provides an inclusive work environment where each person is considered as an individual.
Respects the diversity and dignity of employees and recognizes their merit.