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Regulatory Ops Specialist (II or III)

One of our clients in north Los Angeles is looking for a Regulatory Ops Specialist (II or III) with the following skills and experience: Description of Role/Responsibilities: Client is looking for a Level II or Level III Regulatory Ops Specialist. Looking for someone with AMPLE experience not a junior person. Selected candidate will need to hit the ground running from day one Top 4 Skills: Formatting word documents using eCTD The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. Writing up SOPs (Standard Operating Procedures) Creating Process around development operations work Building global regulatory submissions (eCTD or Non-eCTD) Additional Notes: Experience with publishing eCTD submissions Experience as document and submission publisher including knowledge of regulatory publishing tools (e.g., eCTDXpress, FirstDoc, ISIToolBox) Knowledge of submission compilation, publishing, approval processes, tools and standards Ability to thrive in a rapid paced environment Ability to manage change with a positive approach to the challenges of change for self, team and the business. Sees change as an opportunity to improve performance and add value to the business Good problem and conflict resolution skills Comprehensive knowledge of Microsoft Office and Adobe Acrobat applications Excellent English written and verbal communication skills. What is an eCTD?- The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). It is basically an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. Interested candidates may submit their resumes online or call at 310-906-4780 for further information regarding the position. Find Us on Facebook! Follow Us on Twitter! Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply. Company Profile: Beacon Hill Technologies, a premier National Information Technology Staffing Group, provides world class technology talent across all industries on a contract, direct (permanent), contract-to-direct and project basis. Beacon Hill Technologies' dedicated team of recruiting and staffing experts consistently delivers quality IT professionals to solve our customers' technical and business needs. Beacon Hill Technologies covers a broad spectrum of IT positions, including Project Management and Business Analysis, Programming/Development, Database, Infrastructure, Quality Assurance, Production/Support and ERP roles. Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Pharma and Beacon Hill Technologies by visiting www.beaconhillstaffing.com. We look forward to working with you. Beacon Hill. Employing the Futureā ¢

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