Director, Head of Medical Writing

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:

Key Responsibilities

Medical Writing Leadership / Management

• Provides leadership and oversees management of the medical writing function, building consistent processes to optimize utilization of resources aligned with company priorities.
• Assesses workload and builds Medical Writing team to ensure quality deliverables. Optimally leverages a mix of FTEs and contractors/agencies to ensure flexibility.
• Manages staff, including hiring, performance management, and evaluation. Identifies, interviews, and manages contract medical writers and agencies.
• Assigns medical writers to projects and estimates resource needs, costs, and timelines for document preparation.

Medical Writing Execution

• Ensures Medical Writing activities and provision of deliverables are linked to program strategy by providing leadership and strategic input to projects/study teams at the organization level.
• Ensures that documents meet quality standards in terms of scientific content, organization, clarity, accuracy, format, and consistency, and adherence to regulatory requirements and company guidelines/styles/processes.
• Ensures that all activities are conducted in compliance with relevant regulatory requirements.
• Manages 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.
• Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal, or agency or contractors) or functional area representatives, as required, and ensures adherence to standards.
• Authors documents.
• May represent the Medical Writing function on clinical study teams.

Medical Writing Process & Compliance

• Leads medical writing team in designing and maintaining templates and standards for clinical documents in accordance with ICH guidelines and medical writing best practices. Ensures consistent support and implementation of medical writing standards across all Agios pre-clinical and clinical programs.
• Oversees documents created and edited by the Medical Writing function to ensure compliance with GCP, ICH guidelines, and eCTD requirements, and adherence to Agios’ SOPs and style guide.
• Creates, maintains, manages, innovates, and continuously improves medical writing procedures and SOPs; proactively identify opportunities to improve systems and processes and autonomously leads process improvement initiatives within the medical writing space.

Minimum Requirements:

• Experience: 10+ years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge. Rare Disease experience strongly preferred.
• Experience developing or contributing to the development of a high functioning medical writing team. Direct management experience required.
• Substantial experience with global trials and global regulatory submissions.
• Detailed knowledge of requirements for preparation of key clinical and non-clinical regulatory documents.
• Working knowledge of drug development, biostatistics, pharmacokinetics, regulatory environment, and medical terminology.
• Experience with partnering and managing external vendor relationships.
• Familiarity with relevant ICH, CTD/eCTD and GCP.
• Familiarity with EU privacy and redaction requirements.
• Familiarity with US and EU clinical trial posting and reporting requirements.
• Accurate and detail-oriented with excellent interpersonal skills including the ability to remain calm, professional, diplomatic, and positive when facing challenges.
• Excellent spoken and written English.
• Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
• Ability to work both independently and collaboratively with a team.
• Demonstrated leadership, problem-solving skills, and ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents with constrained timelines.
• Experience in resolving conflicting editorial comments.
• Ability to inspire, lead-by-example and motivate teams to brainstorm solutions and get results.

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.

Agios requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC) on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief, observance, or practice that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.