Director, Medical Writing, Oncology

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 are searching for the best talent for Director Medical Writing Oncology.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-040736

Belgium & Netherlands - Requisition Number: R-055919

United Kingdom- Requisition Number: R-055926

Switzerland- Requisition Number: R-055927

Canada- Requisition Number: R-055928

Remember whether you apply to one or all of these requisition numbers your applications will be considered as a single submission.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

Purpose: The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams driving strategic discussions developing internal medical writers and ensuring adherence to best practices and regulatory guidelines. The Director RegMW has the authority to oversee projects identify risks and implement process improvements while managing internal teams and contributing to organizational initiatives. Additionally the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications leading within a team matrix environment setting functional tactics making strategic contributions and proactively planning for resources. The Director will influence TA-level strategies lead process working groups champion internal standards and improve internal systems and tools.

You will be responsible for:

• Assume overall accountability for decision-making within the organization or TA ensuring alignment with strategic goals.
• Proactively identify potential risks and develop strategies to mitigate them enhancing project outcomes and minimizing obstacles.
• Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables working independently to find effective solutions.
• Write or provide guidance to other writers on all types of clinical regulatory and safety documents taking a proactive lead in content and scientific strategy with complete independence.
• Represent the MW department with decision-making authority in the R&D organization leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments.
• Directly lead or set objectives for team projects and tasks including leading program-level submission indication and disease area writing teams independently.
• Serve as a liaison between team members and senior leadership within a TA or sub-function facilitating effective communication and collaboration.
• Develop implement and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners championing these initiatives to cross-functional team members.
• Mentor support and coach staff at all levels on document planning processes and content providing peer review as needed.
• Maintain and disseminate knowledge of industry company and regulatory guidelines within relevant company systems.
• Participate in industry standards working groups to represent MW and ensure alignment with best practices.
• Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team in close consultation and accordance with the Delivery Unit (DU)
• Head and in line with R&D priorities and TA objectives.
  • Recognized expert medical writer for any document within and across TAs.
  • Accountable for MW resource management and allocation within their portfolio(s).
• Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority.
• Can step in for DU Head in case of absence.
• Is a major contributor to multiple deliverables for the function TA or DU.
• Provides leadership to their writing teams by helping attract and retain top talent developing team members and ensuring organizational effectiveness transparency and communication.
• Responsible for creating an environment where employees feel engaged and empowered and
• take pride in their role responsibilities and deliverables.
• Takes on additional major responsibility with minimal supervision operating at an expert level with accountability for the highest levels of quality:
  • o Cross-functional cross-TA cross-J&J initiative/collaboration.
  • o Larger organizational responsibility (eg manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization.
• Supervises/manages and is accountable for direct reports.
• Sets objectives and agrees on goals for direct reports. Provides performance oversight including providing feedback on performance and development.
• Regularly meets with direct reports to ensure appropriate development projects assignments and issues are resolved.
• Ensures direct reports adherence to established policies procedural documents and templates.
• Participates in hiring staff onboarding new staff conducting career and talent development discussions for staff goal-setting end-of-year performance reviews and compensation planning.
• If applicable frequent engagement with staff and leading discussions on employee development and talent management.

Qualifications / Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg Masters PhD MD) is preferred.
• Minimum of 14 years of relevant pharmaceutical/scientific experience is required.
• Minimum of 12 years of relevant clinical/medical writing experience is required.
• Minimum of 5 years of people management experience is required.
• Experience providing strategic and operational leadership to medical writing teams across all levels with responsibility for setting vision driving functional excellence mentoring leaders and ensuring the successful delivery of highquality compliant clinical and regulatory documentation across the portfolio.
• Expertise in project management and process improvement is required.
• Strong decision-making skills strategic thinking agility broad vision is required.

Other:

• Excellent oral and written communication skills.
• Attention to detail.
• Expert time management for self direct reports (if applicable) and teams.
• Ability to delegate responsibility to other medical writers.
• Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity.
• Expert ability to motivate and develop best in class talent pipeline.
• Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers.
• Creates a positive Credo-based work environment for staff members.
• Shows openness to new ideas and fosters organizational learning.

The expected pay range for this position is $131000 to $225400.

The compensation and benefits information set forth in this posting applies to

candidates hired in Canada. Candidates hired outside Canada will be eligible for

compensation and benefits in accordance with their local market.

Required Skills:

Preferred Skills:

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

The anticipated base pay range for this position is :

$131000.00 - $225400.00

Additional Description for Pay Transparency: