Company DescriptionArtech 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 DescriptionResponsibilities:• 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 timelinesQualificationsSkills:• 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 meetingproject 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 sampleAdditional InformationBest Regards,Anuj Mehta973-967-3402SummaryType: ContractFunction: ScienceExperience level: Mid-Senior LevelIndustry: Pharmaceuticals
SGI Global is seeking an Affirmative Civil Enforcement Investigator for the United States Attorney's Office (USAO) in Baton Rouge, Louisiana... ...by the FTR.SGI Global provides equal employment opportunities (EEO) to all employees and applicants for employment without regard...
...Doctor of Medicine | Surgery - Neurosurgery Location: Munster, IN Employer: The Inline Group Pay: Competitive weekly pay (inquire for details) Start Date: ASAP About the Position Powers Health - Full Time - Friday flexible work schedule...
...Job Description Job Description We are currently seeking a Process Technician to work across all shifts at our Kalamazoo, MI Facility. In this lead position your responsibilities & activities will include: Purge antifreeze from tools Assist in tooling...
...great service, it's great experiences. We are looking for full-time/part-time energetic, friendly and team-oriented cooks.... ...area clean and stocked Requirements: Must be at least 16 years or older Must have reliable transportation to and from work...
...you looking for a flexible, dynamic career where you're in control of your schedule and earning potential? Join our team as a Taxi Driver, where you'll have the freedom to manage your own business while being supported by an established organization. We are seeking motivated...