Director, Medical Writing

• 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.

• 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.

• 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.

• 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.

Johnson & Johnson