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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

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 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.