The Senior Manager, Medical Writing functions as the departmental representative assigned to one or more therapeutic programs responsible to manage the development of all clinical and regulatory documents, publications, and conference materials. This position builds strong relationships with Regulatory Affairs, Biostatistics, Clinical Operations, Clinical Development, Project Management, and other functional areas.
Author, co-author, critically edit, and format regulatory documents including BLAs, NDAs, MAAs, INDs, protocols, CSRs, Investigator Brochures, annual reports, briefing documents, and other regulatory submissions.
Author, co-author, and critically edit publications including abstracts, posters, slide presentations, manuscripts, and review articles.
Manage medical writing contracted with independent consultants, CROs, and other communication vendors.
Manage overall medical writing timelines and resources across project teams (including internal and external resources) ensuring timely completion and quality-assured content.
Serve as the functional area lead on project teams and working with regulatory operations, advise such teams on content, format, and style-guide requirements for documents.
Facilitate consensus review and related meetings.
Assist in the development of medical writing processes, SOPs, and work instructions.
Participate in publication planning.
Maintain subject area expertise related to the company’s investigational products, disease indications, and regulatory and publication guidelines.
Perform quality control of clinical-regulatory documents.
Contribute to the medical writing department budget.
Provide back up support on other programs as required.
Perform miscellaneous other job-related duties and additional duties and responsibilities as assigned.
SKILLS, KNOWLEDGE AND ABILITIES REQUIRED
Degree in life sciences required (BS, MS, PhD, Pharm D, or equivalent);
8 years or more of medical writing experience in the pharmaceutical or biotechnology industry;
Demonstrated success managing contract medical writers;
Previous leadership role in major regulatory filings (NDA, BLA, MAA);
Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses;
Strong clinical expertise enabling development of an initial clinical protocol with KOL and medical input
Excellent writing skills coupled with comprehensive knowledge of the drug development process and regulatory guidelines;
Effective collaborator possessing the ability to foster strong working relationships and build consensus within multidisciplinary teams;
Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision;
Excellent interpersonal and communication skills;
Advanced knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT
Expert user of Microsoft Word, Microsoft Project, PowerPoint, and Excel
Experience with Visio preferred
Experience with Veeva or a similar electronic document management system preferred
Additional Salary Information: this is a full-time position offering salary, full benefits, w/bonus + new hire stock options
Internal Number: SRMAN01316
REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. Our gene therapy product candidates are designed to deliver genes to cells to address genetic defects or to enable cells in the body to produce therapeutic proteins that are intended to impact disease. Through a single administration, our product candidates are designed to provide long-lasting effects, potentially significantly altering the course of disease and delivering improved patient outcomes.
We are currently developing gene therapy product candidates for the treatment of retinal, metabolic, and neurodegenerative diseases. Our product candidates all utilize AAV viral vectors from our proprietary gene delivery platform, which we call our NAV Technology Platform. In addition to our internal product candidate programs, we also selectively license our NAV Vectors to other leading biotechnology companies.