Associate Director, Medical Writer
Company: Jazz Pharmaceuticals
Location: Palo Alto
Posted on: May 3, 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 Associate Director, Medical Writing, is responsible for the
efficient preparation of high-quality, strategically aligned
medical writing deliverables that support the clinical development,
safety and regulatory 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 documentation.
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 clinical
program to ensure effective communication (ie, protocols,
submissions, briefing books, responses to HA questions) underpins
successful clinical development.
- 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
- Analyses 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 aligning, coordinating and building consistent
information and messages across all individual documents within a
clinical program, starting with initial strategic plans, continuing
through study level documents to final program level deliverables
(ie, regulatory submission or publication of key journal articles
for a publication plan).
- Understands where all intended messages will be located across
individual documents within a clinical program, and ensures
alignment of messages across documents.
- Builds convincing clinical or regulatory arguments using logic,
analogy and therapeutic area science.
- Understands issues affecting the design of clinical development
strategy, and understands how study design, data capture and
statistical analysis plan design will affect downstream
- Responsible for ensuring that statements included in the
deliverables are accurate and supported by appropriate data.
- Sets program-level standards (eg, style convention)
- BA/BS or higher and at least 6 years of writing experience in
the pharmaceutical industry
- 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,
including the documents that are required at each stage.
- Expert MS Office skills with a special focus on word
processing, tables, spreadsheets, presentations, graphics and
- Knowledge of ICH and CTD guidelines for clinical and regulatory
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
multicultural sensitivity, build positive and productive
relationships, seek input and value differences.
- Successful track record of leading complex clinical /
regulatory writing projects.
- Excellent organisational and time management skills.
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 , Associate Director, Medical Writer, Other , Palo Alto, California
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