Assoc Local Medication Coordinator

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Support

Job Category:
Professional

All Job Posting Locations:
Beijing, China

Job Description:

Position Summary:



* Primarily contribute to Dept.

business and portfolio centralized supports and process optimization on the investigational products’ label approval, IP supplies, depot management, COA requests handling, etc., with the support of cross functions Q&C, CSC, Procurement, C&G, Legal, HCC and Finance, etc., in line with company’s requirements and business needs.

Maintains key partnerships (e.g.

CSC, JRP/Purchasing, Legal, Finance).


* May contribute to training and mentoring of other CTA.


* Support the Local Trial Manager and Site Manager to ensure optimal management of all documents with logistical and administrative tasks related to trial start-up, execution and closing of clinical trials.


* Ensures central business supports and trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements.

Principal Responsibilities:



* Act as key contact person to review and approve country specific label text.

Verify translation against Master English label and approved country lexicon database, and to ensure label text complies with local requirements.


* Maintain country lexicon, label requirements and distribution databases, if applicable.


* Partner with LTM, CSC, and other cross functions, such as Finance, TC, CLS, etc., to ensure all required supportive documents for drug import license application to be available and obtain drug import license, and to ensure the drug to be imported and shipped to the local medication depot successfully.


* To handle the COA requests, upon the requirements from the sites and maintain the corresponding files, complies with company’s requirements and SOP.


* Act as key contact person to address and resolve the (potential) issues identified, including but not limited on label approval, IP importation, local medication depot management, COA providing, etc., and to provide the strong inputs on the corresponding process optimization with the supports of Functional manager and cross functions, such as CSC, Q&C, Finance, Legal and Procurement, etc., in line with regulation and company’s requirement, as well as business needs.


* May act as SME member, proactively contribute to the process improvement including responsible functi...