Job Description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

 
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit  or follow MMS on LinkedIn.

• 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.

• Medical degree (MD or equivalent), or PharmD.
• Experience with protocol amendments and ICF updates.
• Experience with aggregate data review for ongoing clinical trials.
• Experience in Oncology required.
• 3+ year experience in technical or medical writing preferred.
• 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.

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