Associate Director, Medical Writing, CCTD

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 but not limited to, 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 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.
• 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.
• 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:

• 7+ years as a medical or scientific writer, or equivalent professional or educational experience (eg, graduate degree in life sciences).
• Experience with developing plain language summaries, clinical trial results postings, and redactions.
• Working knowledge of CCTD regulations and standards.
• Ability to interpret and to clearly and succinctly present complex clinical and scientific data.
• Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.
• Demonstrable organizational skills and ability to prioritize, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines.
• Ability to work both collaboratively on a cross-functional team and independently; ability to communicate effectively with team members and other stakeholders.
• Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
• Experience with the advanced features of Microsoft Word; ability to work effectively within a document management system.
  
  

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
• Premium benefits package . We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
• Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
• Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.
  
  

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