Manager/Associate Director, Medical Writing

The Manager, Medical Writing, will work in partnership with cross-functional teams to generate and lead the development of Clinical and Regulatory documents across all LEXEO programs. This role will be responsible for the planning, development, and oversight of study and program-level documents with a focus on accuracy, quality, and compliance. This role will assist in the oversight of external partners and process development initiatives and will be an integral contributor to the completion of department and corporate objectives. To be successful in this position, candidates will possess a commitment to excellence, a patient- and team-focused mindset, knowledge of ICH and health authority guidance, and demonstrated leadership in operational and strategic aspects of document development. The level of this position is flexible, and we are open to hiring either at the Manager or Associate Director level depending on the candidate’s qualifications and experience. Primary Responsibilities

• Draft or contribute to the development of high-quality submission-ready documents across such as protocols, protocol amendments, clinical study reports, study specific documents (eg, ICFs, narratives), investigational new drug (IND) applications/clinical trial applications (CTAs)/biologics licensing applications (BLA) modules, regulatory designations, Investigator Brochures (IBs), development safety update reports (DSURs), or others documents as needed.
• Ensure the quality of deliverables by conducting editorial review of documents (grammar, punctuation, consistency) and completing or managing the quality checking of documents according to LEXEO standards.
• Manage the document development process for deliverables including planning aspects (timeline development, kick-off meetings, communicating scope and accountabilities), project execution (tracking/monitoring progress according to established timelines, conducting team meetings), and project finalization (ensure final agreed content, approval, quality, and compliance).
• Manage or assist with the oversight of medical writing partners (contract or CRO staff) for writing projects, quality control, and publishing work streams.
• Interpret complex scientific data and translate into content appropriate for the intended target audience.
• Apply strategic, critical review principles to documents generated by others.
• Ensure compliance regarding the use of document templates and following standard operating procedures or working guidelines.
• Contribute to medical writing process improvement initiatives including the development of Standard Operating Procedures (SOPs) and working guidelines (eg, style guide and writing resource documents).
• Build and maintain collaborative relationships with cross-functional internal subject matter experts (SMEs) and external partners.
• Keep informed of new regulations and/or guidance.
  
  
  

Required Skills & Qualifications

• The ideal candidate will possess a graduate-level education
• A minimum of 7 to 10 years experience with related work within a pharmaceutical/biotech company or CRO
• Preference is given to candidates with experience in early to late-phase drug development
• Ability to manage multiple projects simultaneously in a fast-paced environment
• Positive and proactive written and verbal communication skills
• Direct experience leading the development of protocols and amendments, clinical study reports (CSRs), IBs, and the ability to generate most types of clinical and regulatory medical writing deliverables with minimal oversight
• Working knowledge of the content and format of the electronic Common Technical Document (eCTD) and document publishing specifications
• Thorough knowledge of the drug development process and applicable regulatory requirements and guidelines (eg, ICH E3, E6, E9)
• Proficiency in Microsoft Office Suite (including MSProject) and Adobe is required; experience with authoring toolbars, template suites, and reference software is desired
• Demonstrated high attention to detail in regard to overall document consistency and also to strategic presentation of information in consideration of future deliverables and development plans
• Ability to adapt and work effectively in changing situations and different program teams.
  
  
  

About Lexeo Lexeo Therapeutics is a New York City-based, clinical stage genetic medicine company dedicated to transforming healthcare by applying pioneering science to fundamentally change how genetically defined cardiovascular diseases and APOE4-associated Alzheimer’s disease are treated. Using a stepwise development approach, Lexeo is leveraging early proof-of-concept functional and biomarker data to advance a pipeline of clinical and preclinical programs. Lexeo successfully completed a $112M IPO in November 2023 and in early March announced a PIPE raising an additional $95M, extending the Company’s runway into 2027. Our work culture for most roles is a hybrid model with days in the New York City office and days working from home. We welcome applications from candidates located across the Northeast and Mid-Atlantic. Remote work can be considered for exceptional candidates. Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment. Base salary dependent on qualifications and overall experience.