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Sr. Manager, Medical Writing

Location: Rockville
Posted on: January 27, 2023

Job Description:

Who we are

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The opportunity

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.

What you'll be doing

  • 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 staff 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.

    We set our employees up for success. To be successful in this role and help us achieve our goals, we are looking for someone with the following skills and qualifications:

    • 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;
    • Prior experience with rare disease indications is preferred;
    • 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;
    • Key Competencies:
      • Professionalism and customer service orientation
      • Communication skills - written and verbal
      • Planning, organizing and multi-tasking
      • Prioritizing and time management
      • Problem assessment and problem solving
      • Information gathering and information monitoring
      • Attention to detail and accuracy
      • Flexibility, adaptability and teamwork

        Preferred Experience and Qualifications

        • Experience in prioritizing, managing, and executing multiple projects utilizing sound project management methodologies
        • Capable of effectively negotiating contracts, bids, and change orders with vendors or contractors for manufacturing and utility systems
        • Working knowledge of typical unit operations in a biotech setting
        • Working knowledge of single use pharmaceutical manufacturing equipment
        • Demonstrates a good understanding of equipment, instrumentation, and materials of construction to design, specify, procure, start-up, fully commission and troubleshoot equipment and systems
        • Knowledge of industry standards and guidelines, such as, ASME BPE, ISPE Baseline Guides and CFR's
          • 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

              Why should you apply?

              By joining REGENXBIO, you will have the opportunity to be a part of a growing company and incredible team passionate about developing novel AAV gene therapy products to our patients.

              We offer a comprehensive and competitive benefit plan which includes market-competitive salaries, an annual bonus program, education assistance, retirement plan with employer match, stock options at all levels, summer hours and more!

              In addition, professional development is important to us. By joining our team, you'll have the opportunity the be exposed to challenging projects and development resources to help you grow personally and professionally.

Keywords: REGENXBIO, Rockville , Sr. Manager, Medical Writing, Executive , Rockville, Maryland

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