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Project Manager I
1 month ago
Schedule: 8 am CT to 4:30 pm CT (or equivalent)
Hybrid is highly preferred but also open for remote.
Job Description:
Business needs for management of CMC and Device Post Approval Changes and Agency responses for client’s product portfolio.
Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines. Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle. Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success. Deliver quality project solutions to business problems or issues within defined budgets and/or timelines. Provide expert project guidance/support proactively through project completion. Provide tracking, reporting, and presentation to management and users.
Top 3-5 skills / experience:
- Strong working knowledge of manufacturing unit operations or CTD structure
- Experience project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents
- Experience working with electronic document management systems
- Superior oral and written communication skills
- Ability to work independently under pressure and manage multiple projects simultaneously
Education:
- Minimum of a BA/BS Degree in Chemical, and/or Biological Sciences/relevant discipline.
Experience Level:
- 1-3 Years
Experience:
- 4 years pharmaceutical or industry related experience.
- 1-2 years in quality systems or cross functional project management
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit .
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Vaibhav Kasera
Email: vaibhavk@ustechsolutionsinc.com
