Bachelor's degree in a technical or science-related discipline or related work experience.
3+ years of experience in Regulatory, Quality or a related area (preferred).
Experience with regulatory submissions or promotional materials review.
Requirements:
Manage the review and approval process for promotional, non-promotional, and internal-use materials, including routing grids per SOP.
Oversee electronic approval systems (Veeva Promomats): user access, training, workflows, IT validation, and vendor coordination.
Collaborate with sponsors and agencies to plan PRC meeting agendas, facilitate discussions, and document outcomes.
Develop and update training resources on the materials review process and Veeva functionality; train sponsors, agencies, and reviewers; generate Veeva metric reports for process improvement and compliance.
Job description
Location: Telecommute
Job Type: Contract
Compensation Range: $40 - 50 per hour
Our pharma industry client is looking for a Marketing Editor to join their team!
Responsibilities:
Manages review and approval process for promotional, non-promotional and internal use materials. Manages electronic approval system, user access, user training and workflows. Supports FDA Ad Promo Submissions. Supports QC and regulatory reviews of the materials.
Coordinate promotional and non-promotional materials review and approval processes
Maintain in-depth knowledge of approval process routing grids per SOP and route the materials for approvals accordingly.
Perform Quality Check review on the materials prior to routing.
Collaborate with sponsors and agencies to develop and plan PRC meeting agenda.
Facilitate the PRC meeting discussions and document outcome in live meetings while conducting meeting efficiently to cover the full agenda.
Collaborate with marketing operations on prioritization for routine approvals as well as during major campaign launches and label updates.
Complete regulatory review of promotional and non-promotional materials, final reviews, reapprovals and other review types as necessary.
Develop and update training resources on materials review process and Veeva functionality. Train sponsors, agencies, and reviewers as needed.
Manage user profiles, training needs and access to the VeevaPromomats to sponsors, agencies, and reviewers.
Serve as a point of contact to Veeva vendor for ongoing maintenance and optimization of Veeva workflows. Assist with Veeva Promomats IT validation.
Generate Veeva metric reports to help with process improvement, resource management and compliance monitoring.
Archive OPDP correspondence per guidance from Reg Ad promo lead.
Contribute to development and update of departmental work instructions.
Prepare materials, form 2253, cover letter and send them over to Reg Operations for publishing and OPDP submission.
Support other departmental initiatives as needed (e.g. process improvements).
Qualifications:
Years of experience/education and/or certifications required:
Bachelor's degree in technical or science related discipline or related work experience.
Preferred: 3 years in Regulatory, Quality or related area.
JobID JN -032026-126836
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 Cella, a randstad digital company, 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, Cella by randstad digital 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.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
