Job Description
Clinical and Regulatory
Strategy Development Drive the clinical
development expand
portfolio and speed
up registrationGet alignments with Global
PDT and obtain
CDRC/LDRC endorsement.
Execution clinical &
registration strategy
Protocol DevelopmentAccountable for protocol
development approval
and amendment of China
stand alone phase I III
and PMC.
Clinical Trial ExecutionFeasibility assessment
Medical monitoring
Regulatory Submission
& InteractionCSA application pre-IND
IND pre-NDA NDA filing
and approval.
Innovation &
Scientific EngagementMISP/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 morePreferred 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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not ApplicableShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
01/31/2026*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Manager
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicine ... View more