Associate Director, Medical Writing

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. Jazz is headquartered in Dublin, Ireland with research and development
laboratories, manufacturing facilities and employees in multiple countries committed to
serving patients worldwide. Please visit
more information.
Brief

Description:

The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables within one or more program.
S/he will work directly with cross functional teams to author regulatory documents (eg, protocols, clinical study reports, briefing books, submission documents, investigator brochures). For programs with multiple deliverables, s/he may be responsible for managing writers. The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation. S/He will mitigate risk associated with medical writing and disclosure processes by contributing to Best Practices and SOPs.
This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions. This role may have line management responsibilities.
Essential Functions/Responsibilities

• Works with the cross functional team to ensure effective communication of data in the respective documents.

• Works with the cross functional team to ensure that communication needs for the clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical program lifecycle.

• Analyzes study level documents for their ability to deliver the information required by the target audience (eg, health authorities).

• Communicates proactively and efficiently within the MW team and across R&D.

• Ensures quality of medical writing deliverables and that work on assigned projects adheres to departmental procedures / practices, and industry / international standards.

• Possible oversight of contract medical writers to ensure efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines.

• Collaboration and strategic partnership with cross functional team members to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives.
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.

• Prior contribution to, and an understanding of, global submissions.

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

• Excellent written and oral communication skills and demonstrated coaching and problem-solving abilities.

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

• Ability to think strategically; demonstrated negotiating skills and resourcefulness.

• Demonstrated ability to manage several projects simultaneously.

• Ability to critically analyze and synthesize complex scientific information.

• High degree of…