Job Description
Clinical and Regulatory
Strategy Development: Drive the clinical
development, expand
portfolio, and speed
up registration;Get alignments with Global
PDT and obtain
CDRC/LDRC endorsement.
Execution clinical &
registration strategy
Protocol Development:Accountable for protocol
development, approval
and amendment of China
stand alone phase I –III
and PMC.
Clinical Trial Execution:Feasibility assessment;
Medical monitoring
Regulatory Submission
& Interaction:CSA application, pre-IND,
IND, pre-NDA, NDA filing
and approval.
Innovation &
Scientific Engagement:MISP/OTSP studies
o Scientific
leadership; SIE(Scienti
fic inputs engagement)
etc.
; Publications
Required Skills:
Accountability, Accountability, Adaptability, Bioinformatics, Chromatography, Clinical Development, Clinical Medicine, Clinical Quality Management, Clinical Research, Clinical Study Design, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Data Analysis, ICH GCP Guidelines, Investigation Procedures, Medical Writing, Non-Disclosure Agreements, Process Improvements, Regulatory Compliance, Regulatory Strategies, Risk Management, Scientific Research, Scopus, Strategic Planning {+ 3 more}Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
noJob Posting End Date:
01/31/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.