Project Specialist III

  • location: Framingham, MA
  • type: Contract
  • salary: $38.25 - $45.01 per hour
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job description

Project Specialist III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

 
location: Framingham, Massachusetts
job type: Contract
salary: $38.25 - 45.01 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • 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
 
skills: Quality control, FDA, Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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