Remote Jobs: Associate Director, Medical Writing (Clinical and Regulatory) – Gene Therapy

Ultragenyx Pharmaceutical Inc.

  • Cambridge, MA


  • Permanent

  • Full-time

Be a hero for our rare disease patients

Ultragenyx is a commercial-stage biopharmaceutical company committed to

developing novel therapies for the treatment of rare and ultra-rare genetic

diseases. The company has rapidly built a diverse portfolio of small molecule,

monoclonal antibody, mRNA and gene therapy candidates with the potential to

address debilitating genetic diseases for which the unmet medical need is high,

the biology for treatment is clear, and for which there are typically no

approved therapies treating the underlying disease.

Developing new treatments for rare genetic diseases is challenging work. It

takes courage, talent, and dedication to look past the easy answers and uncover

new solutions that can make a meaningful impact. At Ultragenyx we push each

other to perform at our very best, because we never lose sight of our mission

to make a difference in our patients lives.

Come join our team during this exciting time of growth and opportunities!

During the COVID-19 Outbreak we are committed to our hiring process. The health

and safety of our employees and prospective employees take priority which means

at this time our process will include remote based web-ex video discussions,

interviews & onboarding.

Position_Summary

ultraimpact Make a difference for those who need it most

The Associate Director, Medical Writing will be responsible for writing and

overseeing the writing of various clinical and regulatory documents, including

distribution of work to contract medical writers or agencies as needed. This is

an individual contributor position with team leadership responsibilities to

support gene therapy indications. The Associate Director, Medical Writing will

work closely with cross-functional teams to ensure the documents are of high

quality and completed in a timely fashion compliant with SOPs, ICH/GCP/

regulatory guidelines, and company goals. The core duties of the Associate

Director, Medical Writing are delineated below.

Responsibilities_Including,_But_Not_Limited_To

o Write, edit, or collaborate on development of high-quality clinical

and regulatory documents (e.g., protocols, investigator brochures,

clinical study reports, INDs, eCTD/NDA clinical summaries, briefing

books)

o Contribute scientifically and strategically and lead submission-

level activities for writing team.

o Ensure smooth and effective document management from start to

finish (i.e., from template to a final approved version), which may

include, but is not limited to: first draft authoring, reference

retrieval, generating bibliographies, editing (e.g., follow house

style guide), and managing various processes (e.g., reviews, QC,

QA, formatting, publishing, document archiving)

o Review, edit, and ensure quality of documents or sections of

documents prepared by functional area representatives and/or

contract writers as required and ensure adherence to standards

o Distill large amounts of clinical and scientific data into

essential elements for graphical display

o Partnering with lead author, oversee document review and comment

resolution meetings with cross-functional teams

o Formulate key messages from clinical study data

o Perform literature-based research to support writing activities

o Develop best practices for authoring and reviewing

o Develop and maintain templates and outlines for key documents

o Some travel to other corporate sites or to conferences may be

required

Technical_Requirements_&_Skills

o BS, MS, or doctorate in a scientific or medical field

o Six+ years in the biotechnology/pharmaceutical industry including

in-house experience preferred

o Experience in Biologics, Gene Therapy or Rare Disease is a plus

o Demonstrated experience in medical writing, editing, and clinical

development; has written protocols, IBs, CSRs; worked on at least

one eCTD/NDA submission a plus.

o Strong leadership, planning, and project management skills, along

with initiative and ability to be productive with minimal

supervision and minimal administrative support

o Demonstrated ability to work effectively in a fast-paced

environment with multiple high priority projects

o Proven ability to develop and implement medical writing processes

and standards

o Exceptional oral and written communication skills

Ultragenyx Pharmaceutical is an equal opportunity employer & prohibits unlawful

discrimination based on race, color, religion, gender, sexual orientation,

gender identity/expression, national origin/ancestry, age, disability, marital

and veteran status. Reasonable accommodation will be provided for qualified

individuals with disabilities and for qualified disabled veterans in job

application procedures, as required by applicable law. If you have any

difficulty using our online application system and need an accommodation due to

a disability, you may contact Talent Acquisition by calling: or

by emailing us at . For electronic email and

mail inquiries, please include a description of your requested accommodation,

your name and contact information.

See our CCPA Employee and Applicant Privacy Notice .

Note to External Recruiters: All candidate activity and open positions are

managed strictly through our Human Resources Department. Our Human Resources

Department kindly requests that recruiters not contact employees/hiring

managers directly in an attempt to solicit business and present candidates.

Please note that failure to comply with this request will be a factor in

determining a professional relationship with our organization. Submission of

unsolicited resumes prior to an agreement set in place between the Human

Resources Department and the recruiting agency will not create any implied

obligation. Inquiries on developing a recruiting relationship with us, may be

directed to: .

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