Position: Sr. Engagement Manager - Medical Affairs Consulting Our organisation is looking for an ambitious Sr. Engagement Manager - Medical Affairs Consulting committed to quality outcomes and sustained growth. This position offers the opportunity to work with a diverse, cross-functional team in a results-oriented culture. Primary Duties and Responsibilities: Review source data and ensure completeness, accuracy, and regulatory compliance. Support IND, NDA, MAA, and dossier submissions with high-quality regulatory documentation. Manage medical coding using MedDRA and WHO Drug Dictionary for clinical trial data. Prepare and maintain essential trial documents including protocols, ICFs, and CSRs. Provide clinical site training on data collection standards and regulatory requirements. Develop SOPs, work instructions, and training materials for clinical operations teams. Conduct benefit-risk assessments and contribute to clinical development strategy discussions. Monitor safety signals and liaise with pharmacovigilance teams for adverse event management. Required Qualifications: Commitment to ongoing professional learning and industry knowledge enhancement. Detail-oriented mindset with the ability to synthesise and present complex information clearly. Bachelor's degree in a relevant discipline; master's degree or professional certification is preferred. Proficiency in relevant software and digital tools specific to the functional area. Strong interpersonal and stakeholder management skills with a client-service orientation. At least 24 years of hands-on experience in a comparable professional setting. Knowledge of ICH E2A-E2F, MedDRA coding, GCP, and global regulatory requirements. Candidates who meet the above requirements are encouraged to submit their detailed CV at the earliest opportunity.