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.
The Senior Manager, Medical Writing, is responsible for writing and overseeing the completion of a broad range of documents in support of company products and projects. This individual will work with the lead MW to develop document messages and write, substantively rewrite, and edit documents companywide for sense, clarity, accuracy, and effectiveness.
This individual will help manage project documents, timelines, and contract writers, as well as ensuring that documents comply with International Committee on Harmonization guidelines, Jazz Pharmaceuticals SOPs, Good Clinical Practices, and Good Publication Practices. As a project team member, this individual will work with global 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 clinical regulatory documents companywide for sense, clarity, accuracy, and effectiveness.
- Work with lead writer and project team to develop document messages and data presentations within submission timelines to meet company objectives.
- 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 Harmonisation guidelines, Jazz Pharmaceuticals SOPs, and Good Clinical Practices.
Required Knowledge, Skills, and Abilities
- At least 4 years of writing experience in the pharmaceutical industry
- 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
Required/Preferred Education and Licenses
- BA/BS or higher 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.