Lifelancer is hiring: Associate Director, Medical Writing, CCTD in Cambridge

Job Title: Associate Director, Medical Writing, CCTD

Job Location: Cambridge, MA, USA

Job Location Type: Remote

Job Contract Type: Full-time

Job Seniority Level: Director

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.

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. 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 and is 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.

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 cross-functional teams to produce high-quality, scientifically accurate documents.
• Manage the writing and completion of documents within established timelines and with high quality.
• Ensure that deliverables meet all applicable regulations and guidelines.
• Assist in designing and maintaining templates and standards for clinical documents.
• Represent the Medical Writing function on clinical study teams.
• Manage external CTTD vendors and consultants.
• Track CTTD book of work.
• Work with IT to implement technology solutions related to clinical trial disclosure.

What you bring:

• 7+ years as a medical or scientific writer or equivalent experience.
• Experience with developing plain language summaries and clinical trial results postings.
• Working knowledge of CCTD regulations and standards.
• Excellent written communication skills and attention to detail.
• Demonstrable organizational skills and ability to manage multiple projects.
• Ability to work collaboratively and independently.
• Working knowledge of drug development and clinical research.
• Experience with advanced features of Microsoft Word.

What we will give you:

• Deliberate Development for professional growth.
• Flexibility to embrace different perspectives and work styles.
• Premium benefits package for health and wellbeing.
• Competitive performance-based compensation.
• Psychological safety to share ideas and take risks.
• Commitment to diversity and community involvement.

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

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