Submissions Specialist - Veeva, Regulatory Compliance
Job Description
Our award-winning agency client is looking for a freelance, Submissions Specialist to start this month, up to 40 hours per week, through at least the end of the year.
This is a HYBRID role that requires three days onsite at the client's Irving office.
The Submissions Specialist will ensure materials for pharmaceutical client projects (emails, websites, graphics, social media ads, TV ads, training materials, etc.) are compliant with approved client standards and ready to submit for regulatory review by the FDA. This role works closely with creatives and requires someone who is detail-oriented, process-oriented and deadline-driven.
Submissions Specialist Responsibilities
- Review content materials against client and FDA requirements
- Annotate references to substantiate specific claims using specific clients' documents in Veeva
- Submit content for legal/regulatory review in Veeva
- Resolve issues in a timely fashion that may require some research and deep understanding of FDA standards and specific clients' workflows
- Proactively and confidently raise challenges and questions
- Interpret gray areas and make informed judgement calls
- Go through extensive training to understand and check against specific client content requirements, manage and follow processes to a T and work effectively in Veeva
Submissions Specialist Highly Preferred Experience
- Veeva Vault or similar regulatory content submissions systems experience
- Regulatory industry experience (pharma, banking, etc.)
- Experience working with creative agency and creatives
- Former project management or traffic management
- Highly detail- and process-oriented and deadline-driven
- Excited by challenge to constantly learn and build on knowledge for efficient review of client content
- Proactive communicator - confident to raise issues and questions.
In this position, you may have access to client or customer systems, confidential and/or proprietary information or data. This position is onsite and requires you to work closely with other individuals in a collaborative team environment.
Benefits
Creative Circle's Freelance Employee benefits package includes eligibility for Minimum Essential Coverage (MEC) medical plan, dental/vision/term life package, discount prescription program, critical illness, accident, tele-behavioral health, and 401(k) plan. Sick leave is provided to Candidates whose assignment work location is in a state or city subject to sick leave laws. A Minimum Value (MV) PPO medical plan, Employee Stock Purchase Plan, and paid holiday eligibility are based on length and dates of service.Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:
Email your resume in Word to:
cody.pickett@jobalert.creativecircle.com
**Please do NOT change the email subject line in any way. You must keep the JobID: : KM22-1847168 -- in the email subject line for your application to be considered.***
Cody Pickett - Lead Recruiter
For Creative Circle to represent you for this opportunity, you must be currently authorized to work in the United States without the need of employer sponsorship for a non-immigrant visa such as a H-1B, TN, or O visa. We do not support or provide training for STEM/OPT programs. Additionally, you must be physically located in and perform the work for our client in the United States.
This job was first posted by Creative Circle on 04/01/2025 and applications will be accepted on an ongoing basis until the position is filled or closed.
Creative Circle is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, or any other characteristic protected by law. Creative Circle will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. If you need a reasonable accommodation in the application process, please contact your Recruiter (the person you'll be interviewing with) or a member of our Human Resources team to make arrangements. United Healthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Creative Circle.
Copyright 1999 - 2025. CreativeCircle, Inc. All rights reserved.
Our award-winning agency client is looking for a freelance, Submissions Specialist to start this month, up to 40 hours per week, through at least the end of the year.
This is a HYBRID role that requires three days onsite at the client's Irving office.
The Submissions Specialist will ensure materials for pharmaceutical client projects (emails, websites, graphics, social media ads, TV ads, training materials, etc.) are compliant with approved client standards and ready to submit for regulatory review by the FDA. This role works closely with creatives and requires someone who is detail-oriented, process-oriented and deadline-driven.
Submissions Specialist Responsibilities
- Review content materials against client and FDA requirements
- Annotate references to substantiate specific claims using specific clients' documents in Veeva
- Submit content for legal/regulatory review in Veeva
- Resolve issues in a timely fashion that may require some research and deep understanding of FDA standards and specific clients' workflows
- Proactively and confidently raise challenges and questions
- Interpret gray areas and make informed judgement calls
- Go through extensive training to understand and check against specific client content requirements, manage and follow processes to a T and work effectively in Veeva
Submissions Specialist Highly Preferred Experience
- Veeva Vault or similar regulatory content submissions systems experience
- Regulatory industry experience (pharma, banking, etc.)
- Experience working with creative agency and creatives
- Former project management or traffic management
- Highly detail- and process-oriented and deadline-driven
- Excited by challenge to constantly learn and build on knowledge for efficient review of client content
- Proactive communicator - confident to raise issues and questions.
In this position, you may have access to client or customer systems, confidential and/or proprietary information or data. This position is onsite and requires you to work closely with other individuals in a collaborative team environment.
Benefits
Creative Circle's Freelance Employee benefits package includes eligibility for Minimum Essential Coverage (MEC) medical plan, dental/vision/term life package, discount prescription program, critical illness, accident, tele-behavioral health, and 401(k) plan. Sick leave is provided to Candidates whose assignment work location is in a state or city subject to sick leave laws. A Minimum Value (MV) PPO medical plan, Employee Stock Purchase Plan, and paid holiday eligibility are based on length and dates of service.Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, but you may also:
Email your resume in Word to:
cody.pickett@jobalert.creativecircle.com
**Please do NOT change the email subject line in any way. You must keep the JobID: : KM22-1847168 -- in the email subject line for your application to be considered.***
Cody Pickett - Lead Recruiter
For Creative Circle to represent you for this opportunity, you must be currently authorized to work in the United States without the need of employer sponsorship for a non-immigrant visa such as a H-1B, TN, or O visa. We do not support or provide training for STEM/OPT programs. Additionally, you must be physically located in and perform the work for our client in the United States.
This job was first posted by Creative Circle on 04/01/2025 and applications will be accepted on an ongoing basis until the position is filled or closed.
Creative Circle is an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, or any other characteristic protected by law. Creative Circle will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. If you need a reasonable accommodation in the application process, please contact your Recruiter (the person you'll be interviewing with) or a member of our Human Resources team to make arrangements. United Healthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Creative Circle.
Copyright 1999 - 2025. CreativeCircle, Inc. All rights reserved.
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