Sr. Manager, Medical Writing
Posted on: January 27, 2023
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
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
- 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
- Perform quality control of clinical-regulatory
- 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
- 8 years or more of medical writing experience in the
pharmaceutical or biotechnology industry;
- Prior experience with rare disease indications is
- Demonstrated success managing contract medical
- Previous leadership role in major regulatory filings (NDA, BLA,
- 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
- 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
- Working knowledge of typical unit operations in a biotech
- Working knowledge of single use pharmaceutical manufacturing
- Demonstrates a good understanding of equipment,
instrumentation, and materials of construction to design, specify,
procure, start-up, fully commission and troubleshoot equipment and
- 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,
- 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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