Senior Medical Writer
Company: Jazz Pharmaceuticals
Location: Sharon Hill
Posted on: May 3, 2024
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Job Description:
If you are a Jazz employee please apply via the Internal Career
site
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global
biopharmaceutical company whose purpose is to innovate to transform
the lives of patients and their families. We are dedicated to
developing life-changing medicines for people with serious diseases
- often with limited or no therapeutic options. We have a diverse
portfolio of marketed medicines and novel product candidates, from
early- to late-stage development, in neuroscience and oncology. We
actively explore new options for patients including novel
compounds, small molecules and biologics, and through cannabinoid
science and innovative delivery technologies. Jazz is headquartered
in Dublin, Ireland and has employees around the globe, serving
patients in nearly 75 countries. For more information, please visit
www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter.
Brief Description:
The Senior Manager Medical Writing is responsible for authoring and
overseeing the completion of a broad range of documents in support
of company products and projects. This individual will work with a
cross functional study team to author and edit documents.
This individual will help manage documents, create and maintain
document timelines, as well as ensuring that documents comply with
the Jazz style guide, and SOPs as well as external regulatory
requirements. As a study team member, this individual will work
with 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.
Essential Functions/Responsibilities
Write and edit lean clinical regulatory documents companywide for
sense, clarity, accuracy.
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
predetermined timeframe.
Ensure that documents comply with International Conference on
Harmonization guidelines, Jazz Pharmaceuticals SOPs, and Good
Clinical Practices.
Required Knowledge, Skills, and Abilities
Exceptional English language skills and ability to write and edit
complex material to ensure accuracy, clarity, and effectiveness
Clear understanding of lean authoring for clinical regulatory
documents
A solid understanding of the clinical development process,
including the documents that are required at each stage
For early development: knowledge of pre-clinical and nonclinical
regulatory requirements and reporting is required
Ability to write and edit complex material to ensure accuracy,
clarity, and effectiveness
Experience with a variety of regulatory and clinical documents
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 of
disciplines
Knowledge of ICH and CTD guidelines for clinical and regulatory
submission documents
Excellent organisational and time management skills and attention
to detail
Required/Preferred Education and Licenses
BA/BS with at least 6 years (or advanced degree with at least 4
years) writing experience in the pharmaceutical industry across
therapeutic areas required. Advanced degree preferred.
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.
FOR US-BASED CANDIDATES ONLY
Jazz Pharmaceuticals, Inc. is committed to fair and equitable
compensation practices and we strive to provide employees with
total compensation packages that are market competitive.
For this role, the full and complete base pay range is
$132,000-$198,000. Individual compensation paid within this range
will depend on many factors, including qualifications, skills,
relevant experience, job knowledge, and other pertinent factors.
The goal is to ensure fair and competitive compensation aligned
with the candidate's expertise and contributions, within the
established pay framework and our Total Compensation philosophy.
Internal equity considerations will also influence individual base
pay decisions. This range will be reviewed on a regular basis.
At Jazz, your base pay is only one part of your total compensation
package. The successful candidate may also be eligible for a
discretionary annual cash bonus or incentive compensation
(depending on the role), in accordance with the terms of the
Company's Global Cash Bonus Plan or Incentive Compensation Plan, as
well as discretionary equity grants in accordance with Jazz's Long
Term Equity Incentive Plan.
The successful candidate will also be eligible to participate in
various benefits offerings, including, but not limited to, medical,
dental and vision insurance, 401k retirement savings plan, and
flexible paid vacation. For more information on our Benefits
offerings please click here:
https://careers.jazzpharma.com/benefits
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Keywords: Jazz Pharmaceuticals, Passaic , Senior Medical Writer, Advertising , Sharon Hill, New Jersey
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