Marc Wilson Lim
Pharmacist | Regulatory Writer
- Role
- Associate Principal Regulatory Writer at Certara
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Marc Wilson Lim
Pharmacist with close to a decade of combined pharmaceutical industry experience across the areas of regulatory writing and pharmacovigilance.
Experience
Associate Principal Regulatory Writer
Apr 2025 — Present
Authored documents per client specifications and guidance documents. Document types include clinical pharmacology/pharmacometrics (PK NCA, PopPK, and ER analyses) and clinical study (CSR) reports; investigator\'s brochure (IB); clinical study protocol; new drug application (NDA) and biologics license application (BLA) eCTD modules 2.7.1 (SBS) and 2.7.2 (SCP); integrated summary of immunogenicity (ISI); and briefing documents.• Served as client advisor, working with all parties to develop strategies for organizing and preparing regulatory documents.• Ushered documents through the review process, conducted comment resolution meetings, and led project teams to consensus.
Education
University of the Philippines
Bachelor's Degree, Industrial Pharmacy
Skills
- Healthcare
- Pharmaceutical Research
- Pharmaceutical Sciences
- Clinical Trials
- Drug Development
- Pharmaceutical Industry
- Drug Safety
- Glp
- Analytical Method Validation
- Pharmaceutical Manufacturing
- Clinical Research
- Clinical Pharmacology
- Quality Assurance
- Teaching
- Pharmacovigilance
- Quality Control
- Pharmacology
- Gmp
- Regulatory Affairs
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