7 days old

Global Labeling Product Leader

Kelly Services
Spring House, PA 19477
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 companys 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:**

Minimum of Bachelors degree in a scientific discipline or equivalent. Advanced degree (MS, PharmD, PhD, or MD) highly desired.

At least 5 years experience in the pharmaceutical industry or health authority, with at least 4 years 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).**

**Why Kelly** **** **?**

With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
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 careerconnect with us today.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect
with us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.


Posted: 2019-08-12 Expires: 2019-09-12

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Global Labeling Product Leader

Kelly Services
Spring House, PA 19477

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