Documentation Specialist II
Discovery Drive, SWDD Swiftwater, PA
Some relevant industry experience is preferred, however, this position does not require heavy regulatory expertise. Editing/ review background and the ability to follow up with internal stakeholders.
Review Committee Process Leads (RCPLs) participate in the formal review process of advertising and promotional materials; manages the day-to-day review process; and validates final production of all advertising and promotional materials; Trains and collaborates with internal and external business partners to ensure compliance with appropriate Medical, Legal, Regulatory, corporate, and US Food and Drug Administration (FDA), rules, regulations and guidance documents; manages business partners and assists with the timely execution of project timelines; Identifies project discrepancies from appropriate rules, regulations and guidance documents that may potentially have a negative impact on the organization and provides recommendations for resolution; and
RCPLs provide final validation of advertising and promotional materials by ensuring all required Review Committee (RC) comments have been resolved and incorporated (estimated US advertising and promotional budget of (USD)50+ million).
% of time
Actively participates in meetings of the Review Committee with particular attention to the review, assessment, and validation of advertising and promotional materials with respect to established MLR, corporate, and FDA rules, regulations, and guidance documents; ensures copyright compliance for reference materials used on advertising and promotional materials
Identifies project discrepancies that potentially may have negative medical, legal, regulatory, corporate, or budgetary impact and provide recommendations for resolution.
Assists in development of MLR training content for new hires (project managers and agency personnel); provides updates on process enhancements to reinforce MLR policies and procedures.
Skills: BA/BS - Communication, Marketing, Business, or relevant discipline Preferred - 5+ years product and customer segment knowledge as it relates to vaccines/pharmaceuticals Preferred - 5+ years of advertising and promotional material review process experience Understanding of CBER, FDA, and AMA/APA style guidelines as they relate to vaccines/pharmaceuticals Excellent written and oral communication skills Excellent time management skills Excellent interpersonal skills Education: BA/BS - Communication, Marketing, Business, or relevant discipline
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.