Associate Director Medical Writing
Company: Jazz Pharma
Location: Palo Alto
Posted on: January 8, 2021
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Job Description:
Overview:Jazz Pharmaceuticals is an international
biopharmaceutical company focused on improving patients' lives by
identifying, developing and commercializing meaningful products
that address unmet medical needs. We are continuing to expand our
commercial product portfolio and our research and development
pipeline in therapeutic areas that can leverage our unique
expertise.Our therapeutic areas of focus include sleep and
hematology/oncology - areas in which we have a deep understanding
of the patient journey and a suite of products and product
candidates to address critical needs.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.Responsibilities: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.Job Functions: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 documents.* Responsible for
ensuring that statements included in the deliverables are accurate
and supported by appropriate data.* Sets program-level standards
(eg, style convention)Minimum Requirements:* 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
effectiveness* 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 templates.*
Knowledge of ICH and CTD guidelines for clinical and regulatory
submission documentsOther 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 therapeutic areas.* Strong influencing
skills, able to lead without formal authority.* 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 Pharma, Palo Alto , Associate Director Medical Writing, Healthcare , Palo Alto, California
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