Job Description

Clinical and Regulatory Strategy Development

o Drive the clinical development, expand portfolio, and speed up registration

o Get alignments with Global PDT and obtain CDRC/LDRC endorsement.

o Execution clinical & registration strategy

Regulatory related interaction and clinical document preparation.

Accountable for protocol development, approval and amendment of China stand alone phase I -III

and PMC.

Required Skills:

Adverse Event Report, Adverse Event Report, Business Registrations, Clinical Development, Clinical Documentation, Clinical Judgment, Clinical Medicine, Clinical Pathways, Clinical Research, Clinical Site Management, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials, Clinical Writing, Cross-Cultural Awareness, Data Management, Drug Regulatory Affairs, Ethical Standards, Legal Document Preparation, Multiple Therapeutic Areas, Patient Recruitment, Pharmaceutical Quality Assurance, Professional Integrity, Protocol Development, Protocol Review {+ 1 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

no

Job Posting End Date:

10/31/2026

*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.

Requisition ID:R410603