Director, Medical Writing

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, 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 working with 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.
• 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.

As Medical Writing Submission Strategist (MWSS):

• Act as the primary interface with the Compound Development Teams (CDTs) at the early stages of submission preparation and as a MW expert for the delivery of Johnson & Johnson Innovative Medicine marketing applications.
• Bring scientific and regulatory submissions expertise to the clinical components of marketing applications, across all TAs.
• Recognized as a subject matter expert responsible for submission strategy in support of multiple submissions across different TAs, starting with collaboration on the early draft label.
• Develop/maintain submission training materials specific to clinical content, and submission document requirements/processes, training teams as needed; and promote optimized planning, execution, and delivery of submissions.
• Support development of and team adherence to Submission Excellence best practices and drives consistency of departmental practices across R&D.
• Lead early strategic submission discussions in collaboration with key stakeholders and senior leadership, focusing on clinical scientific content.
• Hold the cross-functional team accountable for developing the clinical storyboard document, prioritizing and making decisions on activities that impact MW deliverables.

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.
• 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.

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

Hybrid Work