Rhythm Pharmaceuticals Head of Medical Writing (Associate Director / Director level) in Boston, Massachusetts
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. Working at Rhythm means that you are part of a team that?s passionate about transforming the lives of people living with rare genetic disorders of obesity. 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.
Rhythm seeks an experienced and highly motivated Medical Writer with experience managing clinical and regulatory documents for multiple programs. This individual will oversee a team of external Medical Writers to ensure the effective management and timely execution of scientifically accurate, informative, and persuasive documents for regulatory filings, with aligned messaging across documents.
Responsibilities and Duties
Help develop messages and ensure consistency across clinical and regulatory documents. Serve as point person for communication between all writing vendors and internal teams.
Proactively contribute to development and implementation of Medical Writing best practices and improvements leading to efficient systems, processes and tools for authoring/reviewing/editing documents and training of medical writing vendors
Lead Medical Writing vendors to facilitate efficient development, review, and finalization of clinical and regulatory documents.
Includes developing timelines, lining up resources, scheduling review meetings, and follow up activities with reviewers to ensure timely completion of key documents for complex global programs, such as Protocols, Clinical Study Reports, Investigator?s Brochures, Briefing Books, Clinical Summaries, Pediatric Plans, responses to health authorities, etc.
Where needed, act as lead Medical Writer with oversight for clinical sections of eCTDs for global market approval; you will be required to create medically and scientifically accurate, informative, and persuasive/strategic content.
Lead document-related meetings, provide updates to teams during cross-functional meetings, review statistical analysis plans.
Provide document strategy and resource needs for programs
Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents.
Participate in initiatives aimed at improving internal standards and systems
Responsibilities may include initiating projects using external vendors from bid stage through project completion.
Qualifications and Skills
Minimum BS in a scientific or writing discipline; MS or PhD preferred.
5- 10 years of relevant medical writing experience with strong project management skills.
Direct experience in the pharmaceutical/biotech industry with thorough understanding of drug development and strategy for regulatory submissions.
Superior writing and editorial skills, strong data analysis skills, ability to understand complex scientific and clinical information and create consistent strategic messaging for diverse healthcare professional audiences.
Ability to coordinate work of multiple writers and vendor resources across multidisciplinary teams including clinical operations, data management, biostatistics, medical affairs, and pharmacovigilance.
Teamwork and collaboration are a must.
Strong communication and organizational skills.
Strong Clinical Trial development knowledge.
Shows innovation and ability to implement change.
Expert in Word/Adobe/Electronic document management systems.
More about Rhythm
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic disorders of obesity. The company is targeting the melanocortin-4 receptor (MC4R) pathway that is impaired due to genetic variants. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm?s mission is to improve the understanding of these disorders and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company?s clinical development program is currently focused on several rare genetic disorders of obesity, all driven by genetic variants in the MC4R pathway. For healthcare professionals, please visit www.UNcommonObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.