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Regulatory Affairs Senior Associate
Thousand Oaks, CATop 3 Must Have Skill Sets:
1. Veeva system experience for both PromoMats and Regulatory Information Management (RIM) vaults.
2. Project managing experience by proactively handling tasks by monitoring upcoming activities or assisting with daily team workload responsibilities and ability to read and understand written instructions and follow documented process independently.
3. Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents and Creation of Infographics, slides, technical editing of process documents, and proofreading.
Day to Day Responsibilities:
Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) archiving and other process documentation authoring support, Veeva data entry and collection). Create and maintain records in Veeva and SharePoint. Appropriately archive all regulatory documents and agency communications per process regulatory documentation (e.g. Preclearance & Request for Advisory Comments (RFAC) submissions and other FDA communications). Ability to lead and manage Webex meetings and provide meeting minutes.
Description:
Administrative projects as backup support of Operations staff during project period. Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) archiving and other process documentation authoring support, Veeva data entry and collection). Create and maintain records in Veeva and SharePoint. Appropriately archive all regulatory documents and agency communications per process regulatory documentation (e.g. Preclearance & Request for Advisory Comments (RFAC) submissions and other FDA communications). Ability to lead and manage Webex meetings and provide meeting minutes. Experience with Jira, Kanban. Creation of Infographics, slides, technical editing of process documents, and proofreading. Technical editing of process documents. Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents. Experience in labeling and Regulatory document management. Experience in promotional review and approval process. Previous Amgen experience is preferred.
Performance Factors:
1. Relationships with Others: The employee works effectively and relates well with others including superiors, colleagues, and individuals inside and outside the Company. The employee exhibits a professional manner in dealing with others and works, to maintain constructive working relationships.
2. Communication and Contact: The employee communicates effectively both verbally and in writing with superiors, colleagues, and individuals inside and outside the Company.
3. Dependability: The employee can be depended on to complete work in a timely, accurate, and thorough manner and is conscientious about assignments.
4. Ability to read and understand written instructions and follow documented process independently
5. Proactively handling tasks by monitoring upcoming activities or assisting with daily team workload responsibilities
Qualifications:
1. Strong business communication and organization skills
2. Detail oriented
3. MS-Office applications
4. Tableau (preferred)
5. Visio
6. Veeva PromoMats
7. Regulatory experience
8. Copy editing
9. Technical writing
10. Project Management
Pay Rate- between $35 - $40/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"
1. Veeva system experience for both PromoMats and Regulatory Information Management (RIM) vaults.
2. Project managing experience by proactively handling tasks by monitoring upcoming activities or assisting with daily team workload responsibilities and ability to read and understand written instructions and follow documented process independently.
3. Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents and Creation of Infographics, slides, technical editing of process documents, and proofreading.
Day to Day Responsibilities:
Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) archiving and other process documentation authoring support, Veeva data entry and collection). Create and maintain records in Veeva and SharePoint. Appropriately archive all regulatory documents and agency communications per process regulatory documentation (e.g. Preclearance & Request for Advisory Comments (RFAC) submissions and other FDA communications). Ability to lead and manage Webex meetings and provide meeting minutes.
Description:
Administrative projects as backup support of Operations staff during project period. Assist US Promotion Regulatory Representatives to support US Promotion Regulatory activities (e.g. Abbreviated Reviews and system updates for label changes, Regulatory Information Management (RIM) archiving and other process documentation authoring support, Veeva data entry and collection). Create and maintain records in Veeva and SharePoint. Appropriately archive all regulatory documents and agency communications per process regulatory documentation (e.g. Preclearance & Request for Advisory Comments (RFAC) submissions and other FDA communications). Ability to lead and manage Webex meetings and provide meeting minutes. Experience with Jira, Kanban. Creation of Infographics, slides, technical editing of process documents, and proofreading. Technical editing of process documents. Create PowerPoint, Visio, manipulate data in Excel spreadsheets (including pivot tables) and author/update MSWord documents. Experience in labeling and Regulatory document management. Experience in promotional review and approval process. Previous Amgen experience is preferred.
Performance Factors:
1. Relationships with Others: The employee works effectively and relates well with others including superiors, colleagues, and individuals inside and outside the Company. The employee exhibits a professional manner in dealing with others and works, to maintain constructive working relationships.
2. Communication and Contact: The employee communicates effectively both verbally and in writing with superiors, colleagues, and individuals inside and outside the Company.
3. Dependability: The employee can be depended on to complete work in a timely, accurate, and thorough manner and is conscientious about assignments.
4. Ability to read and understand written instructions and follow documented process independently
5. Proactively handling tasks by monitoring upcoming activities or assisting with daily team workload responsibilities
Qualifications:
1. Strong business communication and organization skills
2. Detail oriented
3. MS-Office applications
4. Tableau (preferred)
5. Visio
6. Veeva PromoMats
7. Regulatory experience
8. Copy editing
9. Technical writing
10. Project Management
Pay Rate- between $35 - $40/Hr on W2 based on experience.
"This posting is for Contingent Worker, not an FTE"