Senior Manager, Medical Writing (Early Phase Development)
Company: Disability Solutions
Location: Philadelphia
Posted on: April 18, 2024
Job Description:
If you are a Jazz employee please apply via the Internal Career
siteJazz 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 detailRequired/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 ONLYJazz
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:
Keywords: Disability Solutions, Lower Merion , Senior Manager, Medical Writing (Early Phase Development), Healthcare , Philadelphia, Pennsylvania
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