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 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 a clinical program in obesity and a preclinical program in NASH/MASH. 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 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.

Experience: 

• 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

   

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

Key Skills: 

• 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

Pay Range External Disclosure Statement 

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 position is eligible for a discretionary annual bonus and discretionary stock-based long-term incentives.  In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees’ and their families physical and financial health and overall well-being. These include, but are not limited to, 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. 

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, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. 

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences employees to perform their job duties may result in discipline up to and including discharge. 

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.