Overview • Lead strategic medical writing efforts, ensuring alignment with regulatory and clinical objectives to support impactful submissions and deliverables. • Develop and execute document strategies that enhance compliance and consistency across clinical and regulatory documentation. • Collaborate with cross-functional teams to drive excellence in clinical and regulatory submissions. • Provide leadership and mentorship to medical writing staff, fostering professional growth and operational efficiency. • Champion process improvements, inspection readiness, and adoption of innovative tools and methodologies. • Contribute to strategic planning and resource allocation in collaboration with senior leadership. • Ensure timely delivery of milestones by proactively addressing risks and challenges. • Operate within a hybrid work model, balancing onsite and remote collaboration effectively. Key Responsibilities & Duties • Oversee medical writing deliverables across diverse clinical programs, ensuring quality and compliance. • Lead the development of document strategies for complex regulatory submissions, including NDA, BLA, and MAA filings. • Author, review, and approve clinical and regulatory documents, maintaining scientific rigor and consistency. • Manage internal and external resources, ensuring adherence to performance and quality standards. • Collaborate with cross-functional teams to influence and align regulatory strategies. • Implement solutions to mitigate risks and ensure successful milestone achievement. • Drive operational excellence through continuous process improvements and technology integration. • Support departmental goals and contribute to long-term strategy development alongside senior leadership. Job Requirements • Bachelor’s degree in a relevant scientific field; advanced degree preferred. • Minimum of 10 years of experience in medical writing or related domains. • Proven leadership experience managing teams and external vendors in matrixed environments. • Expertise in leading global regulatory submissions, including NDA, BLA, and MAA filings. • Broad therapeutic area knowledge; neuroscience experience is advantageous. • Exceptional written and verbal communication skills with a focus on scientific accuracy. • Ability to prioritize and manage competing tasks effectively in dynamic settings. • Hybrid work model requiring onsite presence three days per week; relocation support available.