Associate Director, Medical Writing
Company: Jazz Pharma
Location: Palo Alto
Posted on: May 6, 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
The Associate Director, Medical Writing, is responsible for the
efficient preparation of high-quality, strategically aligned
medical writing deliverables that support the early clinical
development requirements of a clinical program. The incumbent will
work with the MW program lead to ensure that strategically aligned
communication points are conveyed in medical writing deliverables
and that the communication points are consistent across program
This role has global responsibilities, including participation in
global teams and interaction with regulatory agencies in multiple
regions as needed.
Drives and develops the messaging strategy within the product
development program to ensure effective communication (ie,
protocols, briefing books, nonclinical [Modules 2.4 and 2.6] and
clinical [Modules 2.7.1 and 2.7.2] for IND submissions and
marketing applications) underpins successful product
* Represents medical writing on the team level to ensure that the
communication needs for clinical data are considered early in the
development program to enable consistency of data presentation and
messaging throughout the clinical development process.
* Works with the MW program lead to develop a messaging strategy
across a program of work.
* Analyzes proposed plans, programs, individual studies and related
documents for their ability to deliver the information required by
the target audience (ie, regulatory authority) in a compelling
fashion with accuracy and consistency.
* Responsible for ensuring that statements included in the
deliverables are accurate and supported by appropriate data.
* BA/BS or higher and at least 6 years of writing experience in the
pharmaceutical industry; early clinical development experience
* Exceptional written and oral communication skills and ability to
write and edit complex material to ensure accuracy, clarity, and
* A solid understanding of the clinical development process, with a
focus on the early clinical development and non-clinical stages of
* Expert MS Office skills with a special focus on word processing,
tables, spreadsheets, presentations, graphics and templates.
* Knowledge of ICH and CTD guidelines for nonclinical, clinical,
and regulatory submission documents
Other Valuable Experience:
* Ability to think strategically with demonstrated negotiating
skills and resourcefulness.
* Ability to manage several projects simultaneously.
* Ability to analyze critically and synthesize complex scientific
information from a range of scientific disciplines and clinical
* Strong influencing skills, able to lead without formal
Demonstrated ability to: work collaboratively with mu
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 Pharma, Palo Alto , Associate Director, Medical Writing, Healthcare , Palo Alto, California
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