“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”
Top 3 Must Have Skills
1. Must have strong CMC Combination Product project management skills (late stage and lifecycle management) and be highly skilled using MS Project tool and the development of complex timelines. NOTE: *The manager will not consider Project Managers within the areas of IT, Supply Chain & Construction. This is a totally different area and out of their expertise.
2. Lead and work together with multiple cross functional teams and projects and establish strategies based on business needs for the on time delivery of new combination product devices.
3. Human Factors experience and Packaging and labeling development and FDA submission experience.
Also: Business Intelligence, E2E Implementation
Day to Day Responsibilities:
"This posting is for Contingent Worker, not an FTE"
- Collaborate with CMC team members in defining clinical and commercial manufacturing requirements
- Solve complex combination product-related problems using a variety of technical and analytical skills
- Identify activities or events that may critically affect the on time delivery of the project and act on or relay that information to appropriate level of management
- Support late stage activities including process validation and PAI preparations
- Coordinate and document activities surrounding complaints received from sites or vendors
- Present metric updates to management and project stakeholders.
- Participate in regularly scheduled meetings with cross functional groups and vendors.
- Handle confidential information and perform duties in strict confidence
- Ability to multitask with varying priorities and projects
- Previous supervisory skills are a plus (management of staff).
- Functional/Technical Knowledge & Skills (including any required proficiency for particular computer programs or applications, if applicable):
- Good knowledge and demonstrated practice of GMP Guidelines
- Experience with regulatory submissions
- Highly proficient in Microsoft Project, Outlook, Word & Excel
- Prior commercial launch experience highly desirable
- Up to 10% travel (including international) may be required
- Ability to thrive in a small group setting with limited administrative support, developing and maintaining collaborative internal and external relationships.
- Excellent organizational skills.