PARC Operations & FDA Submissions Specialist

Teva; West Chester (Chester County); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health insurance

401(k) with employer match

Paid time off

Life and disability insurance

Employee assistance program

Job summary

Teva seeks an Associate III, PARC Operations, to manage materials through Teva’s PARC review process. You will route materials, schedule PARC meetings, and ensure timely completion of all required activities before PARC discussions.

Ideal candidates have 4–6 years of experience in prescription drug advertising review, Veeva proficiency, and knowledge of FDA 2253 submissions. strong organization and teamwork are essential.

Qualifications

• 4–6 years of experience with review and approval of prescription drug advertising and promotion materials.
• Experience with electronic review systems for advertising and promotion (Veeva) preferred.
• Working knowledge of FDA 2253 submission process in eCTD format.
• Excellent organization and follow-up skills.
• Ability to work independently within the PARC structure and with outside Agencies.

Responsibilities

• Route review materials to PARC team members within timelines.
• Schedule and manage PARC meeting dates/times and issue agendas timely.
• Ensure all activities leading up to PARC meetings are completed on time.
• Ensure PARC comments are addressed and understood by participants.
• Document final changes to materials and outcomes of PARC discussions.
• Review and approve material proofs ensuring PARC changes are incorporated.
• Prepare and manage submissions to FDA OPDP within timelines.
• Collaborate with responsible functions to manage material expiry/renewals.
• Author and review PARC process and internal guidance documents.
• Develop and run reports to support metrics and document compliance.

Skills

PARC process experience

Veeva experience

Organizational skills

Independent worker

Education

BA/BS Degree

Tools

Veeva

FDA 2253 eCTD

Job description

Teva seeks an Associate III, PARC Operations, to manage materials through Teva’s PARC review process. You will route materials, schedule PARC meetings, and ensure timely completion of all required activities before PARC discussions.

Ideal candidates have 4–6 years of experience in prescription drug advertising review, Veeva proficiency, and knowledge of FDA 2253 submissions. strong organization and teamwork are essential.