This on-site Regulatory Affairs Specialist II role in Fort Worth, TX is for a mid-level professional with 3-5 years of experience. You will manage the regulatory review process for promotional materials, acting as a central hub for guidance and ensuring all submissions meet compliance standards. The role requires experience with Veeva PromoMats and involves collaborating with marketing teams and preparing documentation for senior management.
location: Fort Worth, Texas
job type: Contract
salary: $50 - 55 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Supports/assists in acting as a centralized knowledge hub of MAP and provides guidance to project owners/agencies/reviewer on the process to streamline material review
- Collaborates with Brand to set prioritization of review to manage review priorities against business needs, assist in triage of materials for appropriate review and provides guidance on submission readiness.
- Supports MAP review meetings to ensure all review requirements and processes are followed, effective time management, and assists in promoting collaborative problem-solving and teamwork.
- Prepares pertinent approval documentation and ensures distribution of the materials submitted to reviewers for compliance review.
- Reviews materials submitted for review to ensure readiness according to established criteria and templates as applicable (e.g. proper referencing and annotations)
- Tracks all submissions to ensure task completion and for monthly reporting purposes (metrics) to senior management
- Ensures effective implementation and use of any electronic review tools
- Assists in identifying team/process/system issues and assists team to address collaboratively, recommending systemic process improvements.
- Reviews, edits and approves all assigned project deliverables against project documentation and specifications prior to client delivery within established timelines
- Supports work of or acts as proof copy editor as needed to ensure that all required changes are addressed, and the material is complete and accurate.
- Prepares pertinent report documentation (e.g., metrics and monitoring reports) and ensures distribution of reports.
- Assists with special projects as needed (e.g. development of new SOPs)
- Remain current on all compliance requirements and processes as they pertain to promotional practices and guidelines established by the corporation.
qualifications:
- Bachelor's degree (Science background will be a plus
- Excellent command of written and spoken English, other major languages are a plus.
- 2 - 3 years of experience.
skills: SOP, Regulatory Affairs Operations, SOP Development, Veeva Vault
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
