Senior Manager, Medical Writing

Senior Manager, Medical Writing

Who we are :

is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make :

Agios Pharmaceuticals is searching for a dynamic Senior Manager, Medical Writing to join our growing Regulatory Affairs & Medical Writing team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. This position reports directly to the Director, Head of Medical Writing. The Senior Manager, Medical Writing will be responsible for clinical regulatory documents. Examples include protocols, CSRs, IBs, clinical sections of submissions, and briefing documents.

What you will do :

• Work with and lead project teams to prepare clinical documents, including but not limited to protocols, CSRs, and IBs to support drug development.
• Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents; contribute to overall project management to facilitate efficient document development and finalization.
• Author documents; Manage the writing and completion of documents and other assigned tasks within established timelines and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes through both internal and external writing resources.
• Ensure that deliverables meet all applicable regulations, standards, and guidelines, including International Conference on Harmonisation (ICH) guidelines and Agios’ style guide.
• Assists Head of MW in designing and maintaining templates and standards for clinical documents in accordance with ICH guidelines and medical writing best practices.
• Represent the Medical Writing function on clinical study teams.
• Assist with medical writing CRO / vendor management.

What you bring :

Work Location :

Location Agnostic : Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events / meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you :

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.