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
...accounting department in Austin. Responsible include assisting in daily cash accounting operations, preparing cash journal entries and... ...This role helps in the execution of the companys daily cash payment and receipt process, ensures accurate allocation of funds across...
...Job Information This is a remote position. We are seeking an experienced Business Consultant with expertise in R&D technology platforms, particularly IBM Engineering Lifecycle Management (ELM) and Ketryx. The ideal candidate will work closely with business stakeholders...
...'Djamena in Chad. Avmax offers the following capabilities: Aircraft Leasing, Airline Operations, Avionics, Component Repairs, Engineering... ...in the Aviation industry. Reporting: The Aircraft Structures Technician reports directly to the Lead A&P Structures...
...Audiologist Or Hearing Aid Specialist OpportunityWe are seeking an Audiologist or Hearing Aid Specialist in the Cranston, RI area who is motivated by his/her career in the hearing industry! This organization is a leading name in the hearing care industry, known for its...
...Company Description Job Description 2nd Hearing Instrument Specialist / Audiologist Sam's Club Altoona, PA, USA Part-time Position: Specialist (HIS or AuD) Job Description Our Mission: "Helping People Hear Better" About this Hearing Specialist / Audiologist...