Senior Manager, Medical Writing

Corporate       ·      Carlsbad, California      ·       Full time

• Locations: Carlsbad, California
• Categories: Research & Development
• Req ID:  10414

Job Description

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.

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

• 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.

Please click here to apply.