Associate Director Of Medical Writing

Job DetailExperience Level Associate DirectorDegree Type Master of Science (MS)Employment Full TimeWorking Type HybridJob Reference 0000018762Salary Type AnnuallyIndustry PharmaceuticalsSelling Points Lead impactful medical writing initiatives for global regulatory success. Collaborate with cross-functional experts to drive innovation and quality. Enjoy a hybrid work environment with growth opportunities.Job DescriptionOverviewLead strategic medical writing initiatives for clinical development programs, ensuring the creation of high-quality regulatory documents aligned with program objectives.Collaborate with cross-functional teams to ensure cohesive messaging and successful regulatory submissions for global healthcare projects.Provide expert guidance in medical writing, contributing to departmental goals and driving process improvements and innovation.Manage resource planning and oversee outsourced writing support to ensure timely and quality deliverables.Develop and implement strategies for complex regulatory submissions, including NDA, BLA, and IND applications.Contribute to the adoption of new tools and technologies to enhance efficiency and quality in medical writing processes.Operate within a hybrid work environment, balancing onsite collaboration and remote flexibility effectively.Support marketing authorization applications and other major regulatory filings with advanced technical expertise.Key Responsibilities & DutiesLead the planning, authoring, and delivery of clinical and regulatory documents, ensuring alignment with project timelines and quality standards.Serve as the primary medical writing lead on program teams, proactively addressing risks and ensuring alignment with strategic goals.Coordinate the development of clinical content for complex regulatory submissions, ensuring consistency and compliance with regulatory requirements.Oversee and manage outsourced writing support, ensuring inspection-ready quality and adherence to timelines.Collaborate with Clinical Development, Regulatory Affairs, and Biostatistics teams to ensure cohesive and effective messaging.Drive initiatives to enhance inspection readiness and optimize resource utilization within the medical writing function.Contribute to the development and implementation of departmental process improvements and new technology adoption.Support strategic clinical development goals through expert medical writing and cross-functional collaboration.Job RequirementsMaster’s degree in a relevant scientific discipline; advanced degree (PhD, PharmD) preferred.Minimum of 8 years of experience in medical writing, clinical research, or related fields.Proven expertise in supporting major regulatory filings, including NDA, BLA, MAA, and IND submissions.Demonstrated ability to lead complex projects and manage competing priorities effectively.Strong communication and collaboration skills, with the ability to influence cross-functional teams.Broad scientific knowledge across therapeutic areas; experience in neuroscience is a plus.Experience with resource planning, vendor management, and the adoption of new tools and technologies.Hybrid work environment requiring onsite presence three days per week.