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Looking for Associate Regulatory Affairs-Contract- 100 % Remote - Thousand Oaks, United States - Unisys
Description
Unisys is an Information Technology and Business Consulting firm providing project-based solutions, software solutions and professional staffing services.Those authorized to work in the United States are encouraged to apply. We are unable to sponsor at this time.
Role:
Associate Regulatory Affairs.
Location- 100% Remote.
Work hours:
preferably PST or MST.
Duration- 12 months plus.
Job id-
AMAGJP
Client:
Amgen.
Job Description:
Job Details:
Ensure the smooth compliant flow of information between all Functional areas, internal and external to GRAAS, local offices, external partners, and regulatory authorities.
The type of qualities/characteristics the hiring manager is looking for in candidates that will work best with their team:Works well collaboratively, as there is a lot of teamwork involved in what we do.
Detail oriented, to be able to monitor data quality.
Comfortable learning new systems/processes. Someone who is able to follow instructions/guides, since we work in a framework based on rules/compliance.
Education background preferred for this role:
Science/Technology-based degrees are preferred OR industry-specific experience.
If the candidate has experience in performing our teams tasks and would be able to do this job, the type of degree would not necessarily matter.
Good communication skills (verbal & written), resourceful critical thinker, detailed.
(Overall, wed need someone who understands the importance of details, since we work so much with monitoring Data Quality and someone who is able to communicate clearly with internal and external teams.
Once training is completed, this individual must then understand how to utilize the tools provided to complete needed tasks, which requires resourcefulness and critical thinking skills.)
Top 3
Must Have Skill Sets:
Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance, including familiarity with US Certificate of Pharmaceutical Product (CPP) process.
Good written and verbal communication skills
Independent time management and prioritization skills and detail oriented
Critical thinking skills
Day to Day Responsibilities:
Maintain Regulatory document management and tracking systems
Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence
Responsible for maintaining the on-site US Certificate of Pharmaceutical Product (CPP) responsibilities, as well as hard copy pickup at company and mailings.
Ensuring Regulatory compliance with SOPs and Regulatory authorities
Provide support to RDA team members and other functional areas, including vendors
Collaboration with external partners/outsourced CROs
Responsible for creating, running, and analyzing report data for potential Veeva RIM system clean-up
Red Flags:
Applicant should be comfortable/adaptable in using and learning new processes/systems and able to have flexibility in their schedule (i.e. starting and finishing the day a bit later if the need arises for coverage).
Interview:
One phone interview per candidate, would like to schedule ASAP.
Thanks
Gangadhar Sadaram
| Recruiting Analyst
Talent Solutions | USA
Unisys | Direct :
|
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