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Director, Medical Writing

Company: Professional Diversity Network
Location: Palo Alto
Posted on: May 3, 2021

Job Description:

Jazz Pharmaceuticals is a global biopharmaceutical company dedicated to developing life-changing medicines for people with serious diseases - often with limited or no options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in key therapeutic areas. Our focus is in neuroscience, including sleep medicine and movement disorders, and in oncology, including hematologic and solid tumors. We actively explore new options for patients including novel compounds, small molecule advancements, biologics and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in more than 90 countries.

We are looking for the best and brightest talent to join our team. If youre 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 youll explore our career openings and get to know Jazz Pharmaceuticals.
Responsibilities: Primary Objective/ Purpose of Position:
The Director, Medical Writing, is a key leadership position in the Medical Writing and Transparency Department. The Director, Medical Writing, is responsible for determining and driving the medical writing strategy for one or more clinical programs, and for the provision of managerial oversight to Medical Writing staff.

As a strategic partner to senior R&D leadership, the incumbent is accountable for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety and regulatory requirements of a clinical program. S/He is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.

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 establishing and maintaining Best Practices and SOPs.

This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions. This role also has line management responsibilities.

Job Functions:
Drives and develops the messaging strategy within a clinical program to ensure effective communication (ie, development plans, submissions, briefing books, risk management plans, responses to HA questions) underpins successful clinical development. Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan). Accountable for medical writing deliverable quality and ensures work on assigned projects adheres to departmental procedures / practices, and industry / international standards
Additional responsibilities:
Efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines Program forecasting, budgeting, and provides support to the department head in resource planning Collaboration and strategic partnership with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives Building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship (defines the scope of work to be outsourced, and is responsible for medical writing vendor oversight on the outsourced deliverables)
Minimum Requirements:
BA/BS or higher and at least 8 years of writing experience in the pharmaceutical industry, solid tumor experience and advanced degree preferred 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 Experience leading 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
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.

Keywords: Professional Diversity Network, Palo Alto , Director, Medical Writing, Other , Palo Alto, California

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