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. This role is a primary liaison with cross‑functional teams, driving strategic discussions, and ensuring adherence to best practices and regulatory guidelines. The Director has the authority to oversee projects, identify risks, and implement process improvements, while working with internal teams and contributing to organizational initiatives.
Responsibilities   Assume overall accountability for decision-making within the organization or 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.
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 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 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.
Medical Writing Submission Strategist (MWSS)   Act as the primary interface with the Compound Development Teams at the early stages of submission preparation and as an 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 therapeutic areas.
Recognize as a subject matter expert responsible for submission strategy in support of multiple submissions across different therapeutic areas, starting with collaboration on the early draft label.
Develop/maintain submission training materials specific to clinical content and submission document requirements/processes, train teams as needed and promote optimized planning, execution, and delivery of submissions.
Support development of and team adherence to Submission Excellence best practices and drive 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   University or college degree in a scientific discipline is required.
Advanced degree (Master’s, PhD, MD) is preferred.
Minimum 14 years of relevant…