Senior Manager, Clinical Trial Disclosure & Transparency
Palo Alto, California
Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT
Apply Job :
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.
Our therapeutic areas of focus include sleep and hematology/oncology areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.
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.
The Senior Manager, Disclosure & Transparency is responsible for preparing global disclosure and transparency deliverables in accordance with global applicable laws, regulations and policies. This role will define and implement processes, and provide leadership to ensure high quality, comprehensive and compliant clinical trial registration and results disclosure on major trial registries (ie, and EudraCT) for all applicable Jazz clinical trials. In addition, the incumbent will support and/or lead transparency activities as directed.
KNOWLEDGE, EXPERIENCE AND SKILLS
* A BS / BA degree or higher; 3+ years in the biopharmaceutical industry with direct experience in transparency and/or disclosure in the biopharmaceutical industry (2 years preferred)
* Deep understanding of global transparency and disclosure requirements; excellent understanding of ICH and CTD guidelines for clinical and regulatory submission documents; understanding of clinical development
* Excellent verbal and written communication skills and excellent interpersonal skills.
* Excellent organization, communication, and time-management skills
* Works effectively within an evolving and dynamic matrix environment; has proven track record to quickly adapt to changing regulations, priorities and deadlines
* Well-developed computer skills including proficiency in MS Office, Adobe, SharePoint and Document management systems.
_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._