Senior Manager, Medical Editing

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description

The Senior Manager, Medical Editing will be responsible for ensuring high quality, submission ready, clinical regulatory documents are created to support regulatory submissions at Wave. 

Experience

• Bachelor’s degree in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience
• 5-8 years of experience in medical editing and/or quality control with expertise in neurology; industry experience preferred
• Board certification from Board of Editors in Life Sciences (BELS), Certificate in Medical Editing from American Medical Writers Association (AMWA), or the equivalent industry certification preferred

Responsibilities

• Maintains familiarity with the current AMA manual of style, FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet regulatory requirements and guidance
• Provides technical support and expertise as appropriate. Conducts training of medical editing contractors. Advises medical writers on data quality control review, compilation of CSR appendices, and editorial standards
• Maintains regulatory submission style guide and associated software
• Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices
• Performs quality control of assigned documents to ensure accuracy
• Performs redaction of clinical regulatory documents prior to health authority submission
• Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work
• Manages assigned projects according to medical writing standard operating procedures
• Monitors timelines for assigned projects and updates the Lead Medical Writer and/or Senior Director, Medical Writing if deliverables are at risk
• Compiles medical writing deliverables (CSR appendices, prior to delivery to Regulatory Operations)

Key Skills

• Strong proficiency in Microsoft Word and Adobe Acrobat Pro
• Excellent attention to detail, including strong copy editing, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills
• Excellent grammatical and communication skills, both written and oral
• Extensive familiarity with the AMA style guide strongly preferred
• Ability to work with minimal supervision on multiple assignments with set deadlines
• Ability to work independently as well as part of a team and keep others informed of the progress and status of projects
• Adaptable to changes in work duties, responsibilities, and requirements
• Knowledge of FDA and EU requirements and ICH regulations 
• Proficient with project management software, eg, SmartSheet

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, prom