Senior Manager Medical Writing Operations – Remote

Senior Manager of Medical Writing Operations, Medical Writing

Agios is a biopharmaceutical company focused on providing medicines for some of the world’s most challenging diseases.

We’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform.

We are leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communities.

We continue to foster a productive research engine that yields new insights and potential therapeutic approaches.

We’re a company that cares about our work, each other, and the people who are counting on us the most.

We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results.

We’re driven to be our best selves, together, so we can reach for the Other Side of Possible.

Agios Pharmaceuticals is searching for a dynamic Senior Manager of Medical Writing Operations to join our growing Medical Writing team.

The Senior Manager of Medical Writing Operations will be responsible for developing and maintaining standardized business processes and operations related to Medical Writing deliverables, which include clinical protocols, clinical study reports (CSRs), nonclinical study reports, Investigator’s Brochures (IBs), and summary documents.

The person in this role may also perform technical editing and quality control (QC) checks of deliverables.

The successful candidate will be detail-oriented, self-directed, and flexible, with an eye for continuous improvement and an eagerness to join our highly collaborative, supportive, and driven group of writers.

Key Responsibilities

• Develop, implement, and maintain standardized business processes, operations, and controlled documents (eg, standard operating procedures [SOPs] and work instructions [WIs]) related to Medical Writing deliverables, as well as tools (eg, job aids, Agios style guide) designed to clarify these processes and support consistency across deliverables
• Provide onboarding and as-needed guidance to internal and external medical writers and project teams regarding standard processes for preparing clinical regulatory documents
• Act as Medical Writing technology subject matter expert (SME) for systems and software including PleaseReview, Veeva Vault (electronic document management system [EDMS]), EndNote, and Litera ChangePro
• Advance the implementation of process initiatives and technologic innovations to improve operational efficiency
• Partner with writers and subject matter experts to develop and maintain compliant document templates
• Upload and review documentation in trial master file and other systems/areas (eg, EDMS)
• Perform QC and technical editing of documents to support the delivery of compliant, accurate, submission-ready documents
• As needed, assist in the development of responses during inspections, or in the development of corrective actions/preventive actions (CAPAs)
• As needed, provide oversight of vendor medical writers; provide input into vendor selection

Minimum Requirements

• Substantial experience (7+ years) in medical writing or a related area such as clinical research, drug development, quality assurance/control, regulatory, report/submission publishing, or product support/R&D, including 3+ years’ experience in process development, technology implementation and maintenance, and/or related areas
• Advanced knowledge of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other regulatory guidelines; demonstrated comprehensive ability to interpret and apply these guidelines
• Demonstrated organizational and issue resolution skills and ability to prioritize, work simultaneously on multiple projects, and complete high-quality deliverables according to tight timelines
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with colleagues
• Demonstrated ability to deliver within agreed-upon internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately
• Demonstrated experience anticipating and addressing capability gaps to meet future challenges, with a commitment to continuous learning and improvement
• Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy
• Experience with the advanced features of Microsoft Word; ability to work effectively within a document management system at an advanced level; facility for learning new programs
• Working knowledge of drug development, clinical and nonclinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology

Preferred Qualifications

• Experience with PleaseReview, EndNote, Litera ChangePro, SharePoint, PerfectIt