MMS is hiring a
Senior Medical Reviewer/Clinical Scientist

Summary

The job is for a Medical Reviewer/Safety Officer in a clinical research organization (CRO) named MMS. The employee will perform data review, guide adverse event coding, prepare reports, lead safety activities, and be responsible for strategies in pre and post marketing risk management. The role requires a medical degree or PharmD, experience with protocol amendments and ICF updates, technical or medical writing experience, and 3+ years of clinical or research experience.

Requirements

• Medical degree (MD or equivalent), or PharmD
• Experience with protocol amendments and ICF updates
• Experience as a clinical scientist who is responsible for timely assessment of the clinical trial data and participation in safety surveillance activities for assigned studies in Phase I-III, including review of medical history, labs, vital signs, medications, and prohibited medications
• Experience in Oncology required
• 3+ year of clinical experience and/ or research experience required
• Excellent knowledge of medical terminology, clinical pharmacology, and regulatory guidelines (ICH, FDA, EMA)
• Excellent scientific writing skills
• Ability to understand clinical data
• Proficiency with MS Office applications
• Strong communication skills
• Strong knowledge of current regulatory practices and domestic and international regulations

Responsibilities

• Works cross-functionally with team members in other service lines
• Perform data review by reviewing all data including demographics, efficacy and safety
• Provide significant expertise as primary medical reviewer of individual adverse event reports
• Guide adverse event coding, retrieval and analysis activities in drug safety and clinical trials
• Aggregate case analysis, safety summaries and safety signal generation
• Lead safety activities on assigned product(s) that may include interactions with other functional groups in the company
• Prepare reports for submission to domestic and international regulatory agencies
• Responsible for strategies in pre and post marketing risk management, as well as keeping abreast of pharmacovigilance methods and trends in published literature and global regulations
• Responsible for strategies in monitoring and analysis of cumulative safety information
• Responsible for drug safety crisis management and risk management plans (RMPs)
• Guide reviews of safety sections of NDA submissions
• Guide regulatory reporting including individual case safety reports (ICSRs), NDA annual report summary statements, and periodic safety update reports (PSURs)
• Guide and coordinate preparation of ad-hoc benefit-risk assessment documents
• Plan cumulative safety information analysis such as signal detection from company or public databases with data mining
• Guide safety updates of company core data sheet and local product labels
• Guide regulatory strategy and preparation of data related safety to regulatory authorities and advisory committees
• Responsible for clinical writing
• Ability to work independently as well as able to integrate with client clinical and safety teams

Preferred Qualifications

3+ year experience in technical or medical writing preferred