Senior Manager, Medical Writing (Remote)

Senior Manager, Medical Writing (Remote)

If you are a current Jazz employee please apply via the Internal Career site.

Jazz Pharmaceuticals is a global biopharma 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, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.

Brief Description:

The Senior Manager Medical Writing is responsible for authoring and overseeing the completion of a broad range of complex documents in support of company products and projects. This individual will work with a cross-functional study team to author high-quality, submission-ready documents.

This individual will have responsibilities ranging from authoring documents to leading the cross-functional review and approval process. S/He will be additionally responsible for creating, maintaining, and communicating 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. The person in this role will have the ability to distill complex information and data into clear, concise messages aligned with regulatory requirements.

Essential Functions/Responsibilities

• Author and edit lean high-quality clinical regulatory documents companywide for sense, clarity, and accuracy.
• Assist in authoring a wide range of documents, including investigator's brochures, clinical study protocols and reports, integrated summaries, nonclinical summaries, and SOPs.
• Create, manage and communicate the document timeline to ensure all reviews are completed in the predetermined timeframe.
• Lead cross-functional review process for all documents being authored.
• Lead comment resolution meetings to ensure internal alignment on documents being authored.
• 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.
• 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 organizational 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.

The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.