Director, Medical Writing

Boston, MA
Full Time
Regulatory Affairs
Mid Level
Company Overview
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of people living with rare neuroendocrine diseases. Working at Rhythm means that you are part of a passionate team dedicated to advancing precision medicines that address the root cause of these rare 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 seeks an experienced and highly motivated Director of Medical Writing (MW) who can independently develop as well as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle. Under minimal supervision, the MW role leads work with cross-functional stakeholders to advance Rhythm’s goal of delivering precision medicines to patients living with rare, neuroendocrine diseases.  This role reports into the Executive Director, Head of Medical Writing.
 
Responsibilities and Duties
  • Author and serve as lead writer for complex clinical and regulatory documents (e.g., protocols and amendments, clinical study reports, Investigator’s Brochures, regulatory submissions and responses to health authority inquiries) and contribute to the clinical study design and regulatory/clinical strategies
  • Drive and/or oversee document execution, such as: define document development steps, implement review and revision processes, develop timelines, assign resources, facilitate document-related meetings, provide cross-functional updates and define data needs, etc. to ensure timely completion of key documents for complex global programs
  • Serve as the Medical Writing Lead on cross-functional core program teams
  • Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents (e.g., Regulatory submissions, Annual Reports and updates, DSURs, PBRERs, Posters and Manuscripts)
  • Provide hands-on oversight of the global clinical trial transparency requirements from study registrations to results postings (e.g., clinicaltrials.gov, EudraCT, CTIS)
  • Proactively contribute to development and implementation of Medical Writing best practices, policies, SOPs and process improvement initiatives leading to efficient and improved standards and systems for authoring, review, editing and finalization of documents
  • Develop and refine templates to improve inter-department/program alignment and efficiency in accordance with standards and regulatory guidelines and requirements
  • Define document development strategy and resource needs for programs, including medical writing vendor engagement and oversight
  • Delegate, oversee, as needed act as lead Medical Writer, and serve as key communicator and liaison between any vendors or service providers and cross functional internal teams, including clinical, medical, pharmacovigilance and regulatory
  • In collaboration with Procurement, responsibilities may include initiating projects using external vendors from bid stage through project completion
  • Contribute and/or lead continuous development of the Medical Writing function including identifying and acting upon areas of opportunity and mentoring of medical writing team members

Qualifications and Skills
  • BS in a scientific or writing discipline preferred; master level or doctoral degree preferred
  • 10+ years of relevant experience including education and/or medical writing experience within pharmaceutical/biotech industry
  • 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 and editorial skills, strong data analysis skills, ability to interpret clinical data and understand complex scientific and clinical information and create consistent strategic messaging for diverse audiences
  • Excellent project and program management experience
  • Ability to  oversee, contribute to and coordinate work of multiple medical writers and vendor resources across multidisciplinary teams
  • Expert in Microsoft Office (particularly Word)/Adobe/Electronic document and reference management systems
  • Detail oriented and strong organizational skills
  • Ability to thrive in a fast-paced environment that is highly collaborative to elevate teamwork, communication and alignment across a matrix organization
  • Commitment to delivering high-quality timely results with a sense of urgency, leading by example, demonstrating agility, and navigating ambiguity and change
  • Passion, excitement and a sense of curiosity for driving research and innovation forward toward a goal of helping 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.

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

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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