USA-Project Specialist III

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Job description

Client Domain/Industry: (Healthcare Services) - Experis, a ManpowerGroup company has an exciting contract opportunity for a Project Specialist III. This position is a 12-month contract for one of our key clients.

Job Titles: Project Specialist III

Location: Framingham, MA

Skills/ Experience Needed:

• 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.


• 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

Job roles and responsibilities:

Reporting to the Director, Global Regulatory CMC, this position will provide Regulatory CMC support for Biologics. 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).

Primary Recruiter: Bhasker Latwal

Recruiter Phone Number: Ext - 7159

Recruiter Email:

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