Senior Medical Writer
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: June 11, 2021
Jazz Pharmaceuticals is a global biopharmaceutical company
dedicated to developing life-changing medicines for people with
serious diseases - often with limited or no options. We have a
diverse portfolio of marketed medicines and novel product
candidates, from early- to late-stage development, in key
therapeutic areas. Our focus is in neuroscience, including sleep
medicine and movement disorders, and in oncology, including
hematologic and solid tumors. We actively explore new options for
patients including novel compounds, small molecule advancements,
biologics and innovative delivery technologies. Jazz is
headquartered in Dublin, Ireland and has employees around the
globe, serving patients in more than 90 countries.
We are looking for the best and brightest talent to join our
team. If you’re looking to be a part of a company with an
unwavering commitment to improving patients’ lives and being a
great place to work, we hope you’ll explore our career openings and
get to know Jazz Pharmaceuticals.
The Senior Medical Writer is responsible for writing and
overseeing the completion of a broad range of documents in support
of company products and projects. This individual will work with
the lead MW to develop document messages and write, substantively
rewrite, and edit documents companywide for sense, clarity,
accuracy, and effectiveness.
This individual will help manage project documents, timelines, and
contract writers, as well as ensuring that documents comply with
International Committee on Harmonization guidelines, Jazz
Pharmaceuticals SOPs, Good Clinical Practices, and Good Publication
Practices. As a project team member, this individual will work with
global colleagues across R&D to ensure high quality documents
are produced in the timeframe provided. He/she will lead meetings
to discuss issues pertaining to the documents and guide the team to
successful resolution efficiently.
- Write and edit clinical regulatory documents companywide for
sense, clarity, accuracy, and effectiveness.
- Work with lead writer and project team to develop document
messages and data presentations within submission timelines to meet
- Provide writing support for a wide range of documents,
including investigator’s brochures, clinical study protocols and
reports, integrated summaries, literature reviews, and SOPs.
- Work with the lead writer to create, manage and communicate the
document timeline to ensure all reviews are completed in
- Ensure that documents comply with International Conference on
Harmonisation guidelines, Jazz Pharmaceuticals SOPs, and Good
Required Knowledge, Skills, and Abilities
- At least 4 years of writing experience in the pharmaceutical
- Ability to write and edit complex material to ensure accuracy,
clarity, and effectiveness
- Experience with a variety of regulatory and clinical
- Experience in a matrix environment
- Excellent written and oral communication skills and
demonstrated problem-solving abilities
- Ability to handle multiple projects and short timelines
- Ability to work cooperatively with colleagues in a wide range
- Knowledge of ICH and CTD guidelines for clinical and regulatory
Required/Preferred Education and Licenses
Jazz Pharmaceuticals is an equal opportunity/affirmative
action employer and all qualified applicants will receive
consideration for employment without regard to race, color,
religion, sex, national origin, disability status, protected
veteran status, or any characteristic protected by law.
Keywords: Jazz Pharmaceuticals, Palo Alto , Senior Medical Writer, Other , Palo Alto, California
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