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Location: Framingham (CDP), MA Description: Our client is currently seeking a Project Specialist III (Professional)]
Title: Project Specialist III (Professional) Duration: 6+ Months contract with high possible extension Location: Framingham, MA 01701 Description:Interacts with RA colleagues world-wide; Coordinates and prepares regulatory document packages to support pre- and post-market changes; Provides project team representation, consults on regulatory project needs and is responsible for coordinating and reviewing required regulatory documentation/submissions. Provides direction in managing information from/to other departments. Monitors and tracks information, ensuring accurate communication of the current status of post-approval change control assessments and submissions; Reviews technical documentation; Recommends/approves changes for manufacturing and compliance, ensuring conformance with existing regulatory approvals; Responsible for determining if changes and deviations are in compliance with regulatory licenses (in all applicable countries). Qualifications Basic qualifications: Bachelors or Master's degree in the Life Sciences or Engineering and at least 3 years of relevant experience in regulatory, manufacturing, technical development or QA/QC, or related fields In-depth knowledge of regulatory requirements for biopharmaceutical development and manufacturing. Preferred Qualifications: BS, MS or PhD in Biology, Chemistry, Engineering or related field. Excellent written and verbal communication skills. Solid understanding of GMPs, FDA regulations and ICH guidance pertaining to drug and/or biologic regulations. Strong understanding of manufacturing processes Excellent organizational skills, demonstrated ability to prioritize multiple projects. Ability to work in a team environment, possessing interpersonal skills to effectively work with other departments at various levels. Excellent communication skills and ability to influence across the broadest of constituencies. Have direct hands-on experience with post-marketing regulatory activities (i.e. AR, CBE-30, PAS, Variations) for biologic and/or drug products Ability to effectively interpret guidance and provide recommendation to key stakeholders. Regulatory, Manufacturing, QA/QC experience Proficient in MS Word, Excel, PowerPoint, MS Project. Ability to set ambitious and realistic targets, drive for results and build accountability. Ability to effectively manage the balance between delegation/empowerment and a hands-on approach Contact: This job and many more are available through The Judge Group. Find us on the web at www.judge.comVacancy expired!