Teva Pharmaceutical Industries West Chester , PA 19380
Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!
The Regulatory Affairs Associate, PARC Operations is responsible for managing materials through Teva's Promotion and Advertising Review Committee (PARC) process. The PARC process supports the review/approval of all product advertising and promotional materials, as well as other related materials, (e.g., disease awareness campaigns, sales training materials, etc.) to assure adherence to established regulatory requirements, corporate standards and procedures prior to use. Responsibilities include:
Routing of review materials to assigned PARC team members within established timelines.
Scheduling and management of PARC meeting dates/times and issuance of PARC agendas in a timely manner.
Assuring that all required activities leading up to PARC meetings are successfully completed within established timelines.
Assuring that all PARC review team comments are addressed and understood by PARC participants.
Documenting any final changes to the materials and any outcomes of PARC discussions and routing of materials for final disposition.
Review and approve material proofs to ensure that all PARC requested changes have been properly incorporated.
Prepare and manage submissions to the US Food and Drug Administration Office of Prescription Drug Promotion (FDA OPDP) within established timelines.
Proactively work with the responsible functions to assure that materials are expired or renewed in accordance with established procedures and timelines.
Three (3) to five (5) years of direct experience with processes related to the review and approval of prescription drug advertising and promotion materials preferred.
Strong working knowledge of at least one electronic review system designed for advertising and promotion materials (Veeva Vault or ZINC) preferred.
Working knowledge of the FDA 2253 submission process preferred.
Ability to work under pressure and adhere to deadlines.
Ability to work well in teams, including but not limited to peers and PARC membership.
Demonstrated organizational and problem-solving skills.
Excellent written and verbal communication skills.
Medical Regulatory Affairs
Teva's Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Nearest Major Market: Philadelphia