Medical Affairs Associate

Employer: KCRN Research, Inc.Location : 12311 Middlebrook Road, STE 200, Germantown, MD 20874Employment Type: On-site, Full-TimeKCRN Research, Inc. is a U.S.-based clinical research organization providing regulatory, statistical, and clinical services to biopharmaceutical sponsors. We are seeking a Medical Affairs Associate to support clinical research and regulatory documentation activities. The position involves coordinating clinical protocol development, preparing scientific and regulatory documents, and assisting in data review and project communications.Responsibilities include:·     Clinical Protocol Development: Assist in the drafting and refinement of clinical study protocols for early-phase and post-marketing trials, ensuring scientific accuracy and regulatory compliance with FDA and ICH-GCP standards.·     Medical Writing & Documentation: Prepare and edit professional regulatory materials, including investigator brochures, clinical study reports, and related clinical documents, in alignment with international research and publication standards.·     Clinical Data Review: Support clinical data verification, quality review, and interpretation using SAS or R, coordinating with biostatistics teams to ensure accuracy and consistency with study endpoints.·     Regulatory & Operational Compliance: Maintain study documentation, track timelines, and ensure adherence to FDA and ethical research guidelines to support inspection readiness.·     Cross-Border Sponsor Communication: Facilitate communication with international sponsors to ensure clear understanding of scientific and regulatory information.Minimum RequirementsDoctor of Pharmacy (Pharm.D.) or equivalent degree in Pharmacy or a closely related field.Preferred Qualifications·     Knowledge of clinical research processes, FDA regulations, and ICH-GCP guidelines.·     Experience in preparing clinical or regulatory documentation.·     Familiarity with SAS, R, or similar statistical tools for data review.·     Strong written and verbal communication skills.·     Bilingual proficiency in English and Korean preferred for communication with international sponsors.Application Instructions  KCRN Research, Inc.ATTN: Jae Kim12311 Middlebrook Road, STE 200, Germantown, MD 20874Email Application: hr@kcrnresearch.com