Documentation Workflow Specialist

Onward Search is a specialized staffing and talent solutions company that helps professionals find top jobs with the nation’s leading brands. We’re seeking a Documentation Workflow Specialist for a hybrid position in Mettawa, IL. This is a 12-month contract with the possibility of extension.

Join our client’s team as a key player in managing the review and approval process for promotional, non-promotional, and internal materials. This role is pivotal in ensuring regulatory compliance and quality across all materials, supporting FDA Ad Promo submissions, and maintaining the electronic approval system. You will play a critical role in facilitating smooth workflows, training users, and ensuring timely approvals to support business goals. This role offers benefits for a 40-hour work week and weekly paychecks (W2) for the duration of the contract.

There is no application deadline for this role.

Responsibilities:

• Oversee the review and approval processes for various materials using Veeva and other workflow applications/tools, ensuring adherence to standard operating procedures.
• Manage the electronic approval system, including user access, training, and workflow optimization.
• Conduct quality checks on materials before routing them for approval.
• Collaborate with sponsors and agencies to develop PRC meeting agendas and facilitate discussions, ensuring efficient coverage of all topics.
• Work closely with marketing operations to prioritize approvals, especially during major campaigns and label updates.
• Perform regulatory reviews and manage final approvals and reapprovals as needed.
• Develop and update training resources on the materials review process and Veeva functionality, providing training to sponsors, agencies, and reviewers.
• Serve as the primary contact for Veeva vendor interactions, assisting with IT validation and workflow optimization.
• Generate metric reports to aid in process improvement and compliance monitoring.
• Archive OPDP correspondence and prepare materials for regulatory submissions.

Qualifications:

• Bachelor’s degree in a technical or science-related discipline or equivalent work experience.
• Minimum of 3 years in regulatory, quality, or a related field.
• Strong document quality-checking skills, organizational abilities, and time management.
• Excellent communication skills, both oral and written.
• Ability to innovate and understand customer needs with minimal supervision.
• Proficiency with computer systems and pharmaceutical software.
• Experience in a complex, matrixed environment, preferably within the pharmaceutical industry.
• Familiarity with prescription drug advertising and promotional labeling (preferred).

Perks & Benefits:

• Medical, Dental, and Vision Insurance.
• Life Insurance.
• 401(k) Program.
• Commuter Benefit.
• eLearning & Ongoing Training.
• Education Reimbursement.

*Eligibility requires working over 30 hours per week on an assignment lasting at least 10 weeks.

If you meet the qualifications and are excited about this opportunity, apply today! Our team will connect with you to discuss next steps, support you through the interview process, and advocate for your success.