Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
Regulatory & Medical Affairs Contractor Job Description
Title: Project Manager, Regulatory & Medical Affairs
Assignment: Contractor status, 6 months renewable, onsite in Princeton
Reports to: VP, Regulatory & Medical Affairs
Individual will assist the VP Regulatory & Medical affairs to address daily and longterm operational needs associated with current INDs, future IND planning, meetings with regulators, consultants, and Key Opinion Leaders. Operational needs span the regulatory affairs and medical affairs functional areas within KBP.
Minimum Skills Required:
Advanced expertise with MS Office, especially Excel. Project management software helpful.
Ability to create planning and tracking tools using MS Office
Basic understanding of GXP
Basic understanding of clinical drug development
Assist with DSUR reports
Maintain database of all regulatory submissions and communications
Maintain regulatory submissions calendar in concert with clinical team and VPs Project Management
Assist with regulatory submissions - - preparation, medical writing, regulatory project management
Assist with preparation of KBP-5074 EOP2 meeting
Assist with preparation of KBP-7072 IV IND
Assist with preparation of KBP-5074 meetings with NCAs and EMA
Assist with ClinicalTrials.gov updates
Maintain publication tracker and assist with discussions with medical writers
Maintain medical conference calendar
Plan and coordinate KOL meetings
Assure KOL invoices are handled expeditiously
Assist clin ops team with IDMC meetings, as necessary
Other duties as assigned.
Requirements: BS in science, nursing, or pharmacy, MBA or PMP certificate would be helpful
Internal Number: RAMA001
About KBP Biosciences Co., Ltd.
KBP Biosciences is a clinical stage biopharmaceutical company located in Princeton NJ. Please see our website for additional information.