R&D Process Technical Writer

Jazz Pharma Palo Alto , CA 94306

Posted 2 weeks ago

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 R&D Process Technical Writer is responsible for supporting R&D Business Process Owners (BPOs) with the development and authoring of R&D owned procedural documents. This role will work at the direction of the Director, R&D Process and Training to support R&D efforts to develop and maintain procedural documents by mapping out process steps in collaboration with BPOs or their delegate, and translating process maps into procedural documents and modifying currently effective documents in a common writing style.

Essential Functions

  • Collaborate with BPOs to create stepwise process flows outlining processes to be documented in procedural documents (e.g. SOPs and Work Instructions)

  • Author documents on behalf of BPOs based on agreed upon process flows

  • Modify currently effective documents into the common writing style

  • Facilitate review and approval of procedural documents including comment consolidation

  • Assist BPOs in navigating Jazz's Electronic Document Management System requirements

  • Provide periodic status reports for ongoing process projects

  • Develops and maintains common writing style document illustrating expected technical writing style for R&D owned procedural documents

  • Performs other activities as directed by R&D Quality management

Minimum Requirements

  • Experience with procedural document development, project management, and Electronic Document Management Systems

  • Experience writing and editing procedural documents (e.g. Standard Operating Procedures, Work Instructions, etc) in a regulated environment

  • Proficiency in Microsoft Office applications including Visio

  • Basic knowledge of GxP principles

  • Experience with the conduct of clinical trials and/or quality management activities preferred

Required/Preferred Education

  • BS or MS degree in Scientific or Clinical discipline preferred

Required Knowledge, Skills, and Abilities

  • 4+ years' experience working in a Technical Writing role in the pharmaceutical industry

  • Ability to multi-task and shift priorities

  • Exceptional organizational skills

  • Ability to communicate effectively, both verbally and in writing

  • Good collaboration and networking skills

Description of Physical Demands

  • Occasional mobility within office environment.

  • Routinely sitting for extended periods of time.

  • Constantly operating a computer, printer, telephone and other similar office machinery.

Description of Work Environment

  • Work indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.

  • Responsibilities may require a work schedule that may include working outside of "normal" work hours, in order to meet business demands (e.g. assisting with health authority inspections)

  • Occasional public contact requiring appropriate business apparel (e.g. assisting with health authority inspections)

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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R&D Process Technical Writer

Jazz Pharma