Associate Director, Medical Writing

Wave Life Sciences • Lexington, MA

13h

About The Position

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

Requirements

• At a minimum, a B.A./B.S. degree in a scientific discipline; PhD/PharmD 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
• Strong proficiency in Microsoft Word, with experience using StartingPoint 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, SmartSheet
• Experience with document management systems, with Veeva experience preferred
• Understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology

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
• 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

Benefits

• company-sponsored medical, dental, vision, life, long and short-term disability insurances, generous paid time off (including a week-long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program

What This Job Offers

• Job Type: Full-time
• Career Level: Director