What are the responsibilities and job description for the Associate Director, Medical Writing, CCTD Job at Agios Pharmaceuticals in Cambri position at Agios Pharmaceuticals?
Associate Director, Medical Writing, CTTD
Who we are :
Agios 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 genetically defined 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 Associate Director, 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 Associate Director, Medical Writing oversees the development of high-quality clinical regulatory documents. The Associate Director, Medical Writing is also responsible for leading and mentoring team members while successfully implementing the vision for the department. This role will primarily focus on developing and implementing departmental strategies for clinical trial transparency and disclosure (CTTD) activities, including, but not limited to, plain language summaries, results postings, and redaction.
What you will do :
- Develop and implement departmental standards for CTTD.
- Provide training and mentorship to team members on CTTD principles.
- Work with and lead project teams to prepare clinical regulatory documents, including plain language summaries, results postings, and redactions.
- 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 the 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 EU Clinical Trial Regulation.
- Assist 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.
- Manage external CTTD vendors and consultants.
- Manage and track CTTD book of work.
- Work with IT, as needed, to implement technology solutions related to clinical trial disclosure.
What you bring :
What we will give you :
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
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