Associate Director - Training & Development

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. 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). 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. 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. For early development: knowledge of pre-clinical and nonclinical regulatory requirements and reporting is required. 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 ability to manage several projects simultaneously. Ability to critically analyze and synthesize complex scientific information. High degree of influencing skills in shaping and developing content and wording. Successful track record of leading complex clinical / regulatory writing projects. Excellent organizational and time management skills and attention to detail. Required/Preferred Education and Licenses BA/BS with at least 8 years (or advanced degree with at least 5 years) writing experience in the pharmaceutical industry across therapeutic areas required. LI-DM1 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. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $154,400.00 - $231,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation.