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Title : SA- CMCD Individual Contributor- 583
State : New Jersey   Date : Sep 26, 2018
Experience Level :  
Position Type : CMCD Individual Contributor      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Bridgewater, NJ


Job Title: CMCD Individual Contributor


Duration:  2+ months (extendable) contract on W2



Duties:



The candidate is responsible for assisting in the post-approval maintenance of products within the portfolio of Global Regulatory CMC & Devices Group, Small Molecule Marketed (SMM) function.


Primary responsibilities will be the following:

Renewal activities according to current SOPs and Global Planning for all markets
Coordination with Industrial Affairs for dossier creation
Publishing of dossier with Reg Ops and coordination with GRA Leads for dossier dispatch
Creation of any response documents and coordination with all partners for completion
Appropriate database management (SHARE, etc.)
Annual Reports (US, Brazil, etc.)
Variation Tracking with Affiliates
Variation Data Entry (SHARE)
Change Control assistance as assigned by manager
Other support activities including administrative documents for all submission types
eCTD Application Forms (MRP,CP, etc.)
 
Develops global regulatory CMC strategies and risk assessments for development projects and/or marketed products (new or marketed chemical entities, biological entities, vaccines and/or consumer health care products) in collaboration with other parts of GRA.  Assures effective involvement with change control systems.  Assures that positive and collaborative relationships are developed with CMC teams to achieve the implementation of appropriate regulatory strategies.  Assures that, for major CMC activities that have a critical regulatory and/or financial impact, appropriate strategies are developed to manage the activities, and risks are identified, communicated and mitigated as necessary.
 

Skills:


Global operational experience with a mid/large-size Regulatory CMC and Devices Organization.  Must have some knowledge of global regulations/guidelines, key Health Authority/Industry thinking and trends, and be capable of resolving strategic technical and regulatory issues.  Should demonstrate initiative, some independent thinking, anticipatory foresight, and be able to communicate effectively to internal and external audiences.   Fluency (oral and written) in English language is strongly recommended.  Potential to be able to mentor and train other contractors is desirable but not essential.  Be profecient in the use of databases and tools (Regulatory databases, Excel, Powerpoint, etc.).


Education:

Minimum of a Bachelor’s Degree; advanced degree (Masters, PhD) in a science/health field (eg, Analytical, Chemistry, Pharmacy, Biological/Biotechnology Sciences etc.), or equivalent, is desirable. An understanding of Regulatory CMC and eCTD content Modules 1-3 through technical pharmaceutical CMC experience (laboratory, manufacturing, etc.)  or direct Regulatory CMC experience is required.




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Many Thanks,   

Sree Kanth
Associate Recruitment Manager
NewAge Clinical,
A Division of NewAgeSys, Inc.
231 Clarksville Road, Suite 200,
Princeton Junction, NJ 08550
Tel#: 609-945-1736, Fax: 609-228-4079
Email: sree@newageclinical.com

Website: http://www.newageclinical.com, www.newagesys.com
Inc 5000 Company for 8th Time 

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