Manager, Regulatory Implementation (RIM) at Parexel
Posted in Other 10 days ago.
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Type: Full Time
Location: Waltham, Massachusetts
Essential FunctionThis position s overall responsibilities are to assist the Regulatory Consulting team both with identification and review of regulatory issues likely to impact Liquent s product suite and with providing support to our clients in the form of presentations and workshops focusing on Liquent s product suite. Liquent s product suite includes regulatory information management, submission management, document management, and submission publishing software and services offerings.Key AccountabilitiesThis position will perform two key functions at Liquent: regulatory advisor, and business process consultant for Liquent.Key regulatory advisor activities include the following: Perform reviews and summarize relevant guidance. Participate, as required, in industry focus groups related to changing regulations.Process Consulting activities include the following: Work on strategic consulting opportunities or as subject matter expert in client billable projects. Assisting with implementation workshops of the Liquent product suite Billable work component will be the majority of time. Work with Sales in support role as needed, including guiding customer towards strengths of Parexel suite of products.The role may be further defined to a specific region, such as the United States, Europe, Japan, or other identified regionQualificationsQualifications:
- BS/BA or equivalent
- Minimum of 5 years in working with Life Sciences organizations in defining requirements for and/or implementation of regulatory solutions and/or experience in regulatory affairs or regulatory operations
- Understanding of regulatory processes from early development through product retirement
- Knowledge and understanding of regional regulations and guidance and ICH guidelines pertaining to Regulatory Affairs and / or Regulatory Operations
- Including IND, NDA, MAA, CTA etc.
- Experience with regulatory information management, document management, and publishing solutions in use by Life Sciences clients, such as InSight Suite, Documentum etc.
- Familiarity with CTD and eCTD specifications and lifecycle concepts
- Demonstrable presentation preparation and delivery skills/experience
- Experience in preparing and delivering workshops (training, business process analysis etc.)
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detailDesirable Skills Involvement in regulatory information management implementation or upgrade project Use of Parexel s suite of products Understanding of emerging regulations such as XEVMPD, IDMP and UDI Understanding of processes and practices in pharmaceutical organisationso e.g. CMC, pharmacovigilance, clinical etc Working knowledge of European regulatory procedures (CP, MRP, DCP) Knowledge of software development and deployment process Understanding of system validation requirements Experience in or full understanding of filing various types of submissions (IND, CTD, NDA, NDS, MAA, Annual Reports, labeling changes, etc.) producing both paper and electronic output for delivery to regulatory agencies Experience with Six SigmaAbility to travel 30-40% mostly within USEEO DisclaimerPAREXEL is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.