DOCUMENTATION ANALYST role is needed for a 6 MONTHS CONTRACT opportunity for Yoh Scientific's client located in NEW BRUNSWICK, NEW JERSEY. The client is an American biotechnology company that discovers, develops and commercializes medicines for cancer and inflammatory disorders. If you meet the requirements, please send me your updated resume to Kelly.Hua@Yoh.Com. "YOU MUST BE ELIGIBLE TO WORK IN THE US WITHOUT SPONSORSHIP."

The primary role is to support the documentation activities for regulatory submissions for biologic products as part of the CMC Strategies team. The CMC group is committed to supporting the biologics network with integrity, reliability, active engagement and cross-functional collaboration.

DUTIES AND RESPONSIBILITIES:
* Support the logistical process for regulatory submissions including pre and post submissions while interfacing across the BMS network.
* Assist with dossier creation and system compliance for regulatory submissions.
* Assist in the facilitation of authoring, review, verification and submission-ready compliance for the finalization of filings.
* Participate in initiatives involved with regulatory filings.
* Participation on various cross-functional project teams, interactions with MS&T, TPT, IDT, SLT and GRS-CMC staff at different BMS sites and other key partners both internal and external to the company are necessary.
* Must possess the ability to support multiple projects and to prioritize work independently.
* Work in a team environment and foster teambuilding for the improvement of processes and enhancement of productivity to align with key business drivers.
* Demonstrate commitment to excellence and bring a high energy level to daily activities as well as involve periods of high intensity work under tight timelines.

REQUIREMENTS AND EDUCATION:

* BS degree required. 1-2 years of direct pharmaceutical work experience preferred. Advanced degree is an asset.
* Excellent organizational, communication and project management skills are required along with proficient navigation of electronic systems.
* Must demonstrate an understanding of the global CMC regulatory guidelines, practices and applications.
* Must have a working knowledge of regulatory submissions for pre and post filings.
* Ability to successfully collaborate with a diverse group of technical professionals and interpersonal styles is required.
* Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines and ensuring the most efficient regulatory process.
* Possess strong interpersonal skills and demonstrates ability to effectively interact with business functions.

Opportunity is Calling, Apply Now!

Recruiter: Kelly Hua

Kelly.Hua@yoh.com

What's In It For You*

We welcome you to be a part of one of the largest global staffing companies to meet your career aspirations. Yoh's network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh's extensive talent community that will provide you with access to Yoh's vast network of opportunities and gain access to this exclusive opportunity available to you.

* Medical, Dental & Vision Benefits

* 401K Retirement Saving Plan

* Life & Disability Insurance

* Direct Deposit & weekly ePayroll

* Employee Discount Programs

* Referral Bonus Programs

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here:
http://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.