Associate Director, Medical Writing at Jazz Pharmaceuticals

Posted in Other 11 days ago.

Location: Philadelphia, Pennsylvania





Job Description:


Associate Director, Medical Writing

Job Locations

US-PA-Philadelphia | US-CA-Palo Alto










Job ID
2021-5819
Category
Research & Development

Overview

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.

Position Profile

The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the early clinical development 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 product development program to ensure effective communication (ie, protocols, briefing books, nonclinical [Modules 2.4 and 2.6] and clinical [Modules 2.7.1 and 2.7.2] for IND submissions and marketing applications) underpins successful product 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.

  • Analyzes 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 ensuring that statements included in the deliverables are accurate and supported by appropriate data.

Minimum Requirements:


  • BA/BS or higher and at least 6 years of writing experience in the pharmaceutical industry; early clinical development experience preferred

  • 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, with a focus on the early clinical development and non-clinical stages of development.

  • Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.

  • Knowledge of ICH and CTD guidelines for nonclinical, clinical, and regulatory submission documents

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 therapeutic areas.

  • Strong influencing skills, able to lead without formal authority.

Demonstrated ability to: work collaboratively with mu

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.


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