06 Sep
|
Jazz Pharmaceuticals
|
Toronto
06 Sep
Jazz Pharmaceuticals
Toronto
Associate Director, Medical WritingJazz Pharmaceuticals is a global biopharma company dedicated to developing life‑changing medicines for serious diseases. The Associate Director, Medical Writing is responsible for the effective preparation of high‑quality, strategically aligned medical writing deliverables across one or more programs.Key ResponsibilitiesWorking with cross‑functional teams to ensure effective communication of data and to align messaging across program documentation.Authoring regulatory documents such as protocols, clinical study reports, briefing books, submission documents, and investigator brochures.Managing writers, overseeing contract medical writers, and ensuring deliverables meet quality standards and departmental procedures.Analyzing study‑level documents for audience suitability (e.G., health authorities) and mitigating risk associated with writing and disclosure processes.Participating in global teams and interacting with regulatory agencies in multiple regions; may have line‑management responsibilities.Required Knowledge, Skills,
and AbilitiesExceptional English language and writing skills; ability to write and edit complex material accurately.Clear understanding of lean authoring and ICH/CTD guidelines for clinical regulatory documents.Solid grasp of the clinical development process and regulatory requirements at each stage.Experience with global submissions and knowledge of pre‑clinical/nonclinical regulatory reporting.Expertise in MS Office, including word processing, tables, spreadsheets, and presentation tools.Strong written and oral communication, coaching, and problem‑solving abilities.Strategic thinking, negotiation, and resourcefulness; ability to managemultiple projects simultaneously.Excellent organizational and time‑management skills with attention to detail.Education and LicensesBA/BS with at least 8 years of writing experience in the pharmaceutical industry across therapeutic areas, or an advanced degree with at least 5 years of experience; advanced degree preferred.Equal‑Opportunity StatementJazz Pharmaceuticals is an equal‑opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.Compensation and Benefits (US‑based candidates only)Base pay range: $154,400.00 – $231,600.00. Additional compensation may include discretionary annual cash bonus, incentive compensation, and equity grants. Benefits include medical, dental, vision insurance, 401(k) retirement plan, and flexible paid vacation. For more information on benefits, visit https://careers.Jazzpharma.Com/benefits.Html.#J-18808-Ljbffr
📌 Associate Director, Medical Writing - $154,400 - $231,600 A Year (Toronto)
🏢 Jazz Pharmaceuticals
📍 Toronto