Kelly Services is currently seeking a Global Labeling Product Leader with Pharmaceutical experience for one of our top Pharma clients in Spring House, PA As a GLP Leader placed with Kelly Services you will be responsible for supporting labeling activities in R&D as part of the Retrospective Labeling Compliance (RLC) Program. Key Responsibilities: Responsibilities include documenting deviations from the CCDSs in accordance with the company's deviations process. Candidate must understand the relationship of local labeling to CCDSs and will work collaboratively with Labeling Working Groups (LWGs) and other relevant stakeholders. Candidate is expected to work independently under the guidance of Global Labeling Centre of Excellence (GL CoE) staff. Candidate will report to the GL CoE Content Head or delegated individual and will be based in or in close proximity to either the High Wycombe UK or one of the New Jersey/ Pennsylvania-based US Janssen office locations. System and business process training will be provided to the candidate. Qualifications, Experience and Skills: Applicants must have 4 + years of previous experience in Authoring Label Content in the Pharmaceutical industry or health authority along with a BS degree in the Scientific field. At least 3 years of experience in regulatory affairs with experience associated with product labeling. Product labeling experience should include authoring text for inclusion in product labeling (CCDS, EUPI, USPI), including drafting text based on scientific source data, supporting rationale, and regulatory requirements, standards and templates, and liaison with subject matter experts and regulatory professionals. Advanced Microsoft Word and Excel skills and experience in Documentum-based document management system. Excellent project management, verbal and written communication skills. As a Kelly Services employee, you will have access to numerous perks, including: Vacation and sick pay Paid holidays 401(k) plan Group medical, vision, dental, life, and short-term disability insurance options Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools Kelly Learning Center offers free courses and trainings Weekly pay Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States immediately and without employer sponsorship (F1 OPT/H1B cannot be considered for this position).
With Kelly, you'll have access to some of the world's highest regarded scientific organizations—providing you with opportunities to work on today's most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you'll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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