Senior Manager, Medical Coding

Senior Manager, Medical Coding 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 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 Coding to join our growing Clinical Data Management team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Senior Manager, Medical Coding will be responsible for delivery of high-quality medical coding for individual clinical trials, clinical development programs, and regulatory submissions (Safety regulatory requirements as well as BLA submissions). He or she will be responsible to develop a long-term coding and dictionary strategy that will help to ensure that Agios meets industry and quality requirements for clinical trial, safety, and post marketing coding in a growing company.

He or she will define and implement coding processes ensuring best practices in medical coding and dictionary management for both clinical trial and the Safety coding. He or she will also serve as a subject matter expert for all topics pertaining to the use of medical coding data in statistical analysis, impact assessment, and safety signaling. This role is critical in ensuring integrity, accuracy and compliance of coded clinical trial data, ultimately contributing the success of clinical research initiatives and regulatory submissions.

What you will do: Responsible for all medical coding deliverables that support Agios' regulatory commitments including submission of safety data and the preparation of the Integrated Summary of Safety (ISS) component of licensing applications. Identify opportunities for process optimization and efficiency enhancements in medical workflows.

Maintain accurate documentation of coding processes, decisions. Preparing coding related reports, during reviews and dictionary upgrades. Develop and maintain coding and dictionary management processes for Agios in collaboration with key stakeholders.

Review Program and study level clinical trial and safety coding performed by vendors for quality and consistency. Responsible for the development and ongoing evaluation of coding conventions to ensure consistency and optimize integration capabilities within and across therapeutic areas and Programs. Identify and mitigate potential risks as needed, implement strategies to address coding related challenges and minimize errors or discrepancies.

Collaborate cross functionally as a SME for DM, Safety, and Biometrics and regulatory. Oversee routine and ad hoc impact analysis with pertinent MDs, particularly those related to bi-annual MedDRA dictionary up versioning; supports Safety in the development of expected lists for all clinical trial IMP and market products. Partner with Technical Systems and IT counterparts to optimize processes and technology that support efficient dictionary management and oversight of vendor quality.

Develop and maintain strong relationships with external vendors performing clinical trial and safety coding, ensuring high quality deliverables, consistent application of coding conventions, implementation, and oversight of metrics to ensure quality and productivity, appropriate resourcing, and process improvements as necessary. Ensure that the vendor performance meets expectations and contractual requirements. May oversee contractor and /or full-time staff.

What you bring: BA in life science, computer science or equivalent or Bachelor of Science in Nursing Strong understanding of end-to-end medical coding processes at sponsor and/or CRO 5-8 years of experience in a medical/clinical research environment. Minimum of 4 years coding experience, minimum of 2 years coding rare disease indications Experience overseeing vendors performing clinical trial and/or safety coding.

Proficiency in the structure, management, and application of MedDRA and WHO Drug dictionaries across the drug development spectrum (Phase I through post marketing safety data management) and at least one EDC system Experience performing Medidata Rave dictionary upgrades, impact analysis and developing and maintaining coding processes and conventions. 2+ years people management experience Knowledge of GCP and other regulations and experience translating regulations into compliant process and SOPs Must have excellent oral and written communication / presentation / negotiation skills. Ability to manage multiple (changing) priorities under tight timelines. Detail oriented, able to identify issues and consistently collaborate to solve problems in a timely manner.

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: 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.