- Provides support to the Regulatory Affairs team and is responsible for validating Global Product Registration (GPR) Library approval record metadata.
- Leverage the Excel tracking sheets and Country Specific Approval record templates to validate the Metadata of the individual approval records.
- Identify out of syncs between specific metadata fields and the approval records.
- Identify approval records that need clarification to reconcile the information and communicate with the contact for the in-country affiliates for resolution.
- Daily support of product releases by preparing Global Trade Services (GTS) licenses for products, countries and business partners allowing shipment of product to achieve departmental and organizational objectives.
- Run blocked order reports, coordinate block order resolution with Regulatory Affairs Specialists, solve routine issues with system and processes and manage resolution of blocked orders within tight timelines.
- Supports all business segment initiatives as identified by divisional management.
- Participates in projects affecting GTS licenses and performs other related duties and responsibilities, as assigned.
- Bachelor’s degree
- 1+ years of experience in a similar role from a regulated manufacturing environment (i.e. medical device, pharmaceutical, etc)
- Proficient with MS Office suite (Word, Excel, Outlook)
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Medical device experience
- Previous experience working in a highly matrixed and geographically diverse business environment.
- Pacific Time Zone
Horizontal facilitates valuable and productive conversations between you and potential employers. We can assist you in growing your career by partnering you with employers that offer challenging assignments. For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. Check out all we have to offer and how you can become part of the Horizontal Talent Team. The pay range for this role is $27 - $39 per hour. This is not a guarantee of compensation, as final offer amount may vary based on factors including but not limited to experience and geographic location.
Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.
In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact firstname.lastname@example.org.
All applicants applying must be legally authorized to work in the country of employment.
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