Associate Director, Medical Writing

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 including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology.

Our diversified pipeline is focused on our obesity, alpha‑1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. 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.

The Associate Director, Medical Writing will partner with Wave subject matter experts to deliver high quality, clinical regulatory documents to support regulatory submissions jects may include writing protocols, clinical study reports, Module 2 summaries, Investigator Brochure’s, briefing books, and other clinical regulatory documents.

• At a minimum, a B.A./B.S. degree in a scientific discipline;
  PhD/Pharm
  
  D in life sciences is a plus
• At least 12 years experience in medical writing with expertise in varied therapeutic areas; industry experience preferred, or 5‑8 years with PhD/PharmD
• Experience working with/coordinating external contractors/consultants

• 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
• Acts as project lead on multiple projects, including oversight of the work of contract medical writers
• Attends team meetings on an agenda‑driven basis and contributes to program goals, key messages, and timelines
• Manages assigned projects according to medical writing standard operating procedures, including the conduct of kick‑off meetings, drafting documents, reviewing statistical outputs, reconciling team comments, holding roundtable meetings, and completing other medical writing tasks as needed to ensure completion of high‑quality documents
• Creates and manages timelines for projects and updates the Head of Medical Writing if deliverables are at risk
• Contributes to improvements to medical writing procedures to improve efficiency and productivity

• Strong proficiency in Microsoft Word, with experience using Starting Point templates preferred
• Excellent attention to detail, strong scientific background, writing, data integrity review, accuracy, problem solving, organizational, presentation, and project management skills
• Strong interpersonal skills, a team player
• 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
• Able to work independently as well as a 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, Smart Sheet
• Experience with document management systems, with Veeva experience preferred
• Understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology

The annual base salary range for this position is $167,000 - $226,000. The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity.

This…