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Head of Medical Writing

Company: Intellia Therapeutics
Location: Somerville
Posted on: May 3, 2021

Job Description:

Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values:One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We arent constrained by typical end rails, and we arent out to just treat people. Were all in this for something more. Were driven to cure and motivated for change. Just imagine the possibilities of what we can do together. Why Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values:One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done. We want all of our people to go beyond what is possible. We arent constrained by typical end rails, and we arent out to just treat people. Were all in this for something more. Were driven to cure and motivated for change. Just imagine the possibilities of what we can do together.How you will Achieve More with Intellia:Reporting to the Vice President, Development Operations, you will be responsible for creating, authoring, and leading the management of key documents for programs, regulatory filings, clinical studies and external publications, such as clinical protocols (and amendments), clinical study reports, subject consent forms, investigators brochures, product dossiers, integrated safety and efficacy summaries, and other documents required for regulatory submissions, abstracts, posters and this opportunity, you will collaborate with and actively participate in cross functional teams, such as clinical operations, data sciences, regulatory affairs, medical, biostatistics, pharmacovigilance/safety, new product planning, program management, corporate communications. In addition, you may partner with Key Opinion Leaders (KOLs), Contract Research Organizations (CROs), co-development partnersResponsibilities:Sound understanding of clinical research, drug development, required regulatory guidancesDevelopment and management of global data transparency plans for each development program, which may include study participants, patients, HCPs, and the public.Data transparency planning experiences, includingEnsure compliance with disclosure requirements on public websitesShare data with both study subjects and researchers (PhRMA/EFPIA commitments)Maintain alignment with journal publicationsEvaluate, analyze, and interpret the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, scientific rigorContribute to statistical output plan concerning organization and table layout for a specific documentProject manage, strategic design, planning, team input and reviewsPerform literature-based research to support writing activitiesParticipation in industry wide initiatives, both nationally and globallyQualifications:5-10 years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industryA Bachelors, Masters, PharmD or Ph.D. in a life science of health disciplineA solid understanding of ICH guidelines, GxP, and relevant regulatory requirements Demonstrated understanding of standard clinical document types (i.e., protocol, investigators brochure, clinical study reports, etc.) and experience as a lead author with such documentsProficiency with templates and style guidesExcellent communication skills, both oral and writtenStrong interpersonal, negotiation, verbal, and written communication skillsStrong organizational and meeting skills and attention to detailExperienced in resource planning and management experience with virtual teamsTakes ownership of a given assignment, solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team membersEEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Job InfoType:Full timeLocation: Cambridge, MASDL2017

Keywords: Intellia Therapeutics, Somerville , Head of Medical Writing, Other , Somerville, Massachusetts

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