Associate Director, Medical Writing

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. 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.

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

• 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

Qualifications and Skills

• 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

This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs.  This role may involve some travel.

The expected salary range for this position is $160,000 - $240,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.

More about Rhythm
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

Inherent in our core values is the commitment to act ethically and with integrity in all we do.

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work in Massachusetts.

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