Associate Director/Director, Medical Writer

Job DescriptionWave 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 preclinical program in 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.DescriptionThe Medical Writer role partners with Wave’s subject matter experts (SME) to prepare and deliver high-quality clinical and regulatory documents in support of clinical trials and regulatory submissions for multiple programs. This role will be responsible for authoring and/or developing clinical and nonclinical regulatory documents. This position can be remote or located in Lexington, MA.ExperienceAt a minimum, a B.A./B.S. degree in a scientific discipline; PhD/PharmD in life sciences is a plusAt least 8-15 years of relevant industry experience as a medical/regulatory writerExperience working with/coordinating with external contractors/consultants.ResponsibilitiesIn collaboration with the relevant SMEs, write regulatory documents including, but not limited to, Investigator’s Brochure, clinical study protocol and clinical study report; nonclinical and clinical Summary DocumentsPartner with the Regulatory Strategy Leads for the development of briefing packages for regulatory authority interactions in various regions; of global regulatory documents such as IND, CTA, NDAManage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverablesProactively identify the need for, engage and oversee contract medical and/or regulatory writing resourcesManage the document review, address comments and deliver scientifically accurate documents that meet regulatory requirements and industry best practicesCreate and maintain standard operating procedures or work instructions for preparation and maintenance of compliant medical and regulatory writing deliverablesAttend team meetings on an agenda-driven basis and contribute to program goals, key messages, and timelines discussionsConduct and/or oversee quality control reviews of clinical and regulatory documents; implement the required changesRecommend improvements to the document preparation processes and templates to enhance efficiency and productivityManage and/or oversee timely and compliant registration of clinical trials, information updates, and posting of results in trial registries such as clinicaltrials.govKey SkillsExcellent writing and communication skillsStrong interpersonal skills; a team playerFlexibility to function well within a team environment and within condensed timelinesStrong project management and organizational skillsUnderstanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminologyAbility to comply with company and/or industry style guides and templatesExcellent attention to detail related to consistency, grammar, syntax, and scientific accuracyTechnical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems

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