Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: Clinical Labeling Operations
Location: Thousand Oaks, CA
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Job Description:
Essential Functions:
- Responsible for the coordination of new clinical labeling implementation with Regulatory Affairs Labeling, Quality Assurance Labeling, Supply Chaing Labeling BPO, PM s and multiple packaging sites worldwide.
- Creates labels content and maps content to the appropriate fields in Bartender.
- Creates Business Continuity Labels and maps contents to the appropriate fields.
- Reviews clinical final product label content and Bartender mapping to ensure all content matches source documents and text is mapped to the appropriate fields.
- Liaises with Regulatory Affairs Labeling colleagues to obtain correct text, negotiate timelines and ensure that all requirements have been met.
- Manages the completion of operational excellence projects where prior precedents may not be set and outcomes require executing without prior experience.
- Authors standard operating procedures, guidelines and work instructions.
- Collaborates with team members to meet departmental goals and objectives.
- Completes labeling updates as assigned.
- Highly capable at directing and coordinating project work.
- Strong verbal, technical writing and interpersonal skills.
- Proficient in Microsoft Office applications.
- Knowledge of FDA and cGMP standards as well as regulatory guidance documents.
- Prior experience in pharmaceutical or other regulated industry is required.
- Prior experience in clinical or commercial supply chain.
- Familiarity with artwork/labeling production.
- Familiarity with Bartender software is bonus.
- 6+ years of relevant experience and a BS or BA or 4+ years of relevant experience and a MS.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
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Numbers & Facts
| Location | Thousand Oaks, CA |
| Industry | Computer/IT Services |
| Salary | $47–$52 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
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