Kelly Services Program Coordinator- Regulatory Information Management /Identification of Medici in Cambridge, Massachusetts

Program Coordinator - Regulatory Information Management /Identification of Medicinal Products in Cambridge, MA

5 month contract

Job Responsibilities:

This role will be coordinating work across 2 major initiatives. One set of work will be tied to our client approach to IDMP (Identification of Medicinal Products), and the activities specifically tied to the introduction of the European Medical Agency (EMA) introduction of underlying infrastructure services, called SPOR. This near term activity will be engaging across groups, primarily within R&D, and largely regulatory to complete the data review of the provided controlled vocabularies for accuracy as industry, and from our client’s perspective, as well as managing the feedback on changes required back to EMA services. While IDMP in depth is not required, there is a preference for someone who has sufficient context, thus an individual familiar with regulatory data and processes, and someone who is familiar with current XEVMPD (EMA Article 57) would be the best fit. The other set of work is in pre-work developing the implementation plan for upgrading our Regulatory Information Management (RIM) platform. Note, the focus for this role is not the system component; rather, it is with the organization, facilitation and work related to the overhaul of business processes that are being re-introduced within the context of Regulatory business practices which will enable the company to move forward with a return to a more standard deployment of our RIM system. Thus, someone who is familiar with regulatory data and processes is the primary requirement. Depth/experience is agnostic of specific RIM systems, though a level of familiarity with the RIM industry landscape and capabilities is a plus.

Why Kelly?

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 99 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.

As a Kelly Services employee, you will have access to numerous perks, including:

Exposure to a variety of career opportunities as a result of our expansive network of client companies Career guides, information and tools to help you successfully position yourself throughout every stage of your career Access to more than 3,000 online training courses through our Kelly Learning Center Weekly pay and service bonus plans Group- rate insurance options available immediately upon hire*

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.

*Available for purchase and administered by a designated third-party vendor

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

Why Kelly®? 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 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 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 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 2016 was $5.3 billion. Visit kellyservices.com 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.]]

Category: Biotech/Clinical/R&D/Science