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Senior Manager, Medical Writing (Early Phase Development)

Company: Jazz Pharmaceuticals
Location: Philadelphia
Posted on: April 3, 2024

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 and follow @JazzPharma on Twitter.
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.

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.

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
Ability to handle multiple projects and short timelines
Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents
Excellent organisational and time management skills and attention to detail

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. 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.

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.
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.

Keywords: Jazz Pharmaceuticals, Philadelphia , Senior Manager, Medical Writing (Early Phase Development), Advertising , Philadelphia, Pennsylvania

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