Overview
Purpose: The Director of Regulatory Medical Writing (RegMW) is a leader with extensive medical writing expertise for documents across various therapeutic areas. This role serves as a primary liaison with cross-functional teams, drives strategic discussions, develops internal medical writers, and ensures adherence to best practices and regulatory guidelines. The Director, RegMW oversees projects, identifies risks, implements process improvements, manages internal teams, and contributes to organizational initiatives. The role may guide lead medical writers on one or several compounds with the same or different indications, lead within a team matrix environment, set functional tactics, make strategic contributions, and proactively plan resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools.
Responsibilities
* Assume overall accountability for decision‑making within the organization or a therapeutic area, 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 medical writing 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 therapeutic area or sub‑function, facilitating effective communication and collaboration.
* Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with 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 medical writing and ensure alignment with best practices.
* Set the strategy and operational execution for their portfolio(s) within the medical writing team, in close consultation with the Delivery Unit and aligned with R&D priorities and TA objectives.
* Lead and contribute as a recognized expert medical writer for documents within and across therapeutic areas.
* Be accountable for medical writing resource management and allocation within their portfolio(s).
* Provide leadership to writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
* Create an environment where employees feel engaged and empowered, and take pride in their role and deliverables.
* Take on additional major responsibilities with minimal supervision, operating at an expert level with accountability for high‑quality output, including cross‑functional and cross‑TA initiatives and broader organizational responsibilities.
* Supervise/manage direct reports, set objectives, and provide performance oversight and development.
* Participate in hiring, onboarding, and talent development discussions; conduct goal‑setting and performance reviews; contribute to compensation planning.
Qualifications
* 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.
* Minimum of 12 years of relevant clinical/medical writing experience.
* Minimum of 5 years of people management experience.
* Expertise in project management and process improvement.
* Strong decision‑making skills, strategic thinking, agility, and broad vision.
* Excellent oral and written communication skills.
* Attention to detail.
* Exceptional time management for self, direct reports (if applicable), and teams.
* Ability to delegate responsibility to other medical writers.
* Ability to lead and influence by example, stay focused, demonstrate integrity, and motivate others.
* Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers.
* Creates a Credo‑based work environment for staff members and openness to new ideas, fostering organizational learning.
Compensation and Benefits
* The expected pay range for this position is $160,000 to $276,000.
* Eligible for an annual performance bonus in accordance with applicable plan terms.
* Eligible to participate in company‑sponsored benefit programs (medical, dental, vision, life insurance, disability, and group legal insurance).
* Eligible to participate in the company's consolidated retirement plan and savings plan (401(k)).
* Eligible for the long‑term incentive program.
* Time off benefits include: Vacation, Sick leave, Holiday pay, Work, Personal and Family Time, Parental Leave, Bereavement Leave, Caregiver Leave, Volunteer Leave, and Military Spouse Time‑Off (details may vary by location).
* Additional information can be found through the company careers site.
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