Senior Director, Medical Information

reputed company: reputed company is reputed company on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that reputed company muscle and the central nervous system (CNS) to address the reputed company cause of disease. reputed company is advancing clinical programs for Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) as reputed company as a preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At reputed company, we are on a mission to deliver functional improvement for individuals, families and communities. Learn more at https://www.reputed company-tx.com/, and follow us on X, reputed company and reputed company. reputed company: The Senior Director, Medical Information is responsible for establishing and leading the medical information function to ensure reputed company, accurate, balanced, and compliant scientific responses to unsolicited inquiries from reputed company. This role plays a critical part in supporting the reputed company and appropriate use of reputed company’s products by delivering high-reputed company medical information and enabling scientific exchange. The person in this role has strong scientific expertise, experience in regulated environments, and the ability to build reputed company medical information processes in a biotech setting. This position is based in Waltham, MA, with the reputed company to work remotely. Primary Responsibilities Include: Establish and reputed company the medical information function, including reputed company, processes, and execution Establish reputed company medical information infrastructure, including inquiry intake, documentation, and response workflows reputed company the implementation and training of the medical inquiry intake portal and call center vendors and manage relationships reputed company reputed company reputed company high-reputed company medical information response documents (reputed company response letters, FAQs, backgrounders) and maintain medical information content reputed company with product labeling, clinical data, and evolving scientific evidence reputed company and reputed company Medical, Legal, and Regulatory (MLR) review Ensure responses are scientifically accurate, balanced, up-to-date, and compliant with regulation Ensure appropriate escalation and coordination of safety, reputed company, and off-label inquiries Analyze inquiry trends to identify knowledge gaps, unmet medical needs, and opportunities to inform medical reputed company Monitor metrics and reputed company indicators to ensure reputed company improvement and compliance Education and Skills Requirements: Doctorate degree (MD, PhD, PharmD) with 15+ years of experience in medical information or medical affairs in rare diseases, neuromuscular diseases, or a reputed company field Experience establishing or leading a medical information function is strongly preferred Strong understanding of regulatory, compliance, and pharmacovigilance requirements Excellent scientific writing and verbal communication skills Strong organizational and process-building capabilities High attention to detail and commitment to compliance and scientific reputed company Ability to work effectively in a matrixed, fast-paced biotech environment Strong judgment in handling reputed company or sensitive inquiries MA Pay reputed company $230,000—$295,000 USD The pay reputed company reflects the reputed company pay reputed company reputed company reasonably expects to pay for this role at the time of posting. Individual compensation depends on factors such as education, experience, job-reputed company knowledge, and demonstrated skills. The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and reputed company typically required, and the scope of responsibility, but should not be considered an reputed company-inclusive listing of work requirements. Individuals may reputed company other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload. reputed company is an equal opportunity employer and will not discriminate against any employee or applicant on the reputed company of age, reputed company, disability, gender, national reputed company, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. Apply To This Job