Associate Director, Medical Writing
$160k - $240kFull-time
Rhythm Pharmaceuticals
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
Rhythm is seeking an experienced, highly motivated Associate Director of Medical Writing (MW) to independently author and oversee clinical, regulatory, medical, and safety documents across the development lifecycle. Reporting to the Head of Medical Writing, this role will partner with cross-functional stakeholders to advance Rhythm’s mission of delivering precision medicines to patients living with rare neuroendocrine diseases. The ideal candidate brings strong scientific judgment, regulatory writing expertise, and the flexibility to thrive in a fast-moving, evolving organization.
Responsibilities and Duties
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview
Rhythm is seeking an experienced, highly motivated Associate Director of Medical Writing (MW) to independently author and oversee clinical, regulatory, medical, and safety documents across the development lifecycle. Reporting to the Head of Medical Writing, this role will partner with cross-functional stakeholders to advance Rhythm’s mission of delivering precision medicines to patients living with rare neuroendocrine diseases. The ideal candidate brings strong scientific judgment, regulatory writing expertise, and the flexibility to thrive in a fast-moving, evolving organization.
Responsibilities and Duties
- Drive document execution for complex global programs by defining development steps, timelines, resources, review processes, data needs, and cross-functional communications to deliver key documents on time, including protocols, clinical study reports, investigator brochures, regulatory submissions, and response documents
- Lead medical writing activities for assigned studies and programs, serving as the primary liaison among vendors and cross-functional teams
- Ensure accuracy and consistency across clinical, medical, regulatory, and pharmacovigilance documents by providing expert review of study- and program-level materials, including regulatory submissions, annual reports and updates, DSURs, PBRERs, posters, and manuscripts
- Support global clinical trial transparency activities from study registration through results posting, including clinicaltrials.gov, EudraCT, and CTIS
- Strengthen the MW function by developing processes, standards, and capabilities that support consistent, high-quality document delivery
- Define document development strategies and resource plans for medical writing activities
- Contribute to clinical development planning by bringing strategic medical writing perspective, creative ideas, and practical solutions that strengthen program execution, regulatory readiness, and cross-functional decision-making
- Bachelor’s degree required; advanced degree preferred and minimum 8 years of relevant medical writing experience
- Direct experience in the pharmaceutical/biotech industry with an advanced understanding of requirements for clinical trials and drug development, regulatory submissions, pharmacovigilance reporting and medical communications
- Superior writing, editing, project management and data interpretation skills with demonstrated ability to communicate complex clinical and scientific information clearly and consistently to diverse audiences
- Experience overseeing and coordinating the work of multiple medical writers and vendor resources across multidisciplinary teams
- Highly skilled in Microsoft Office, particularly Word, as well as Adobe, electronic document and reference management systems, with demonstrated aptitude for quickly learning and adopting new technologies, including AI-enabled tools
- Detail oriented with strong organizational skills
- Comfortable operating in a rapidly changing environment, where priorities evolve and competing demands require sound judgment, flexibility, and the initiative to take ownership, drive issues to resolution, and move work forward even when the path is not fully defined
- Passion and curiosity for advancing research and innovation that can help patients and caregivers with rare, unmet medical needs
We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. At Rhythm our core values are:
- We are committed to advancing scientific understanding to improve patients’ lives
- We are inspired to tackle tough challenges and have the courage to ask bold questions
- We are eager to learn and adapt
- We believe collaboration and ownership are foundational for our success
- We value the unique contribution each individual brings to furthering our mission
Vacancy posted a month ago
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