Regulatory CMC Technical Associate
artechBridgewater (NJ)
About the role
Company Description:
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.
Job Description:
Author Module 3 submission documentation according to eCTD requirements for New Drug Application (NDA) Prior Approval Supplements (Client), Changes Being Effected (CBE-0 and CBE-30), and annual reports. Compile, review, and submit DMF annual updates, amendments, letters of authorization, and customer notifications. Participate in team meetings as a representative of IA with both internal and external cross-functional project teams. The Regulatory CMC Technical Associate may be called upon to author technical reports. The candidate must be able to adhere to local and global SOPs to meet pre-established project milestones and timelines
Qualifications:
BA/BS in a scientific discipline - Chemistry or Biology are preferred Master s Degree a plus 4+ years of pharmaceutical regulatory affairs experience Strong knowledge of NDA, ANDA, MAA, BLA, CTA, or IND submissions experience Expertise with Microsoft Office Suite, Electronic Document Management Systems. Proven experience working with authoring templates and tools Excellent multi-tasking skills and ability to manage multiple competing projects while meeting project timelines Required to communicate with management when issues arise Must have the appropriate technical background and desire to learn and assimilate new information Proven ability to work independently and as a member of a team Capable of interacting with technical groups and understand complex issues pertaining to CMC, packaging, and testing Superior written and verbal communication skills in the English language Excellent proofreading skills A working knowledge of cGMPs The potential candidate may be called upon to provide a writing sample Keywords: CTD, CMC, eCTD, FDA, Client, CBE, API, DMF, cGMP, templates Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: 973.967.3348 | Fax: 973.998.2599 Connect with us on - LinkedIn | Facebook | Twitter
Summary
Type: Contract
Function: Research
Experience level: Mid-Senior Level
Industry: Pharmaceuticals
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
More like this