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UPCOMING EVENTS

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ECTD Group Meetings

These meetings have resumed as quarterly get togethers for 2017

Click to see details 

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Job Postings

 

Date Posted

Company

Position

  8/8/2017 DCRI Sr. Medical Writer

This role has the potential to turn into a full regular position! The Senior Medical Writer will be responsible for planning, writing, and editing submission documents across multiple therapeutic areas and in compliance with ICH, FDA, and global regulatory guidelines and requirements. Assignments will include acting as coordinator and lead writer in the compilation and writing of clinical study reports, summary sections of regulatory submissions, protocols and investigators brochures for investigational drugs, devices, biologics and/or combination products.

  7/25/2017 Manpower Import/Export Compliance Program Supervisor
Chemial Import/Export Compliance Program Supervisor position will serve as the Subject Matter Expert and the primary internal contact for chemical product import/export regulatory compliance. Implement and maintain process to comply with US regulations for the movement of goods from the US to Brazil and other Latin American countries. Research pharma and chemical regulatory legislation and guidelines regarding DEA, EPA, EAR,ITAR,TSCA,NRC,DOT. Evaluate and update compliance database. Compile data and complete regulatory submissions to governmental agencies. Manage third-party compliance service provider relationships and projects. Coordinate and negotiate with regulatory authorities. Develop US Freight Forwarder requirements, documenting SOP's. Manage processes to secure and retain Powers-of-Attorney for export companies with Freight Forwarders. REQUIRED to have a 4-yr degree in a science field, 4 yrs exp in regulatory affairs, import/export, min of 2 years in International Trade Compliance. Knowledge with Import: CFR19 - Customs Duties, DEA. Understanding of chemistry testing methods, chemical characterization, supply chain processes, transportation, Global Trade Mgmt, Licensed Customs Broker and/or Certified Export Specialist is preferred.  Job ID 2258362
  7/25/2017 Manpower Chemical Import/Export Compliance Specialist

Specialist will serve as primary internal contact for chemical product import/export regulatory compliance. Receives, organizes, audits, prioritizes, processes and verifies information pertaining to goods manifested for shipping to clients. Follow all required pharma and chemical regulatory legislation/guidelines re: DEA, EPA, EAR, ITAR, TSCA, NRC, and DOT. Interact with clients, suppliers, US Customs Brokers and mgmt. REQUIRED: 4-YEAR DEGREE in science field and 2 yrs exp in regulatory affairs and 1 year International Trade Compliance. Understanding of various analytical chemistry testing methods and US Pharmacopeia Methods and Validation techniques, exp with AES and formal Entry. Basics with MS, GC, LC/MS, FTIR, UV-VIS; chemical characterization (NMR, Mass, IR, KF) and other associated assays including Chromatographic columns and Reference standards.

Job ID 2197666

  7/10/2017 Nupulsecv Regulatory and Quality Affairs - Medical Devices

Implement and executive regulatory strategies developed by the senior management team * Participate with all internal teams to implement overall regulatory strategy * Lead preparation of, including writing, organization, and submission of all regulatory documents in US and outside US, may include IRB and CMS submissions, as assigned. * Interface with regulatory agencies, consultants, internal team members * Maintain regulatory and quality documentation including Regulatory Master File and Design History File * Direct quality systems efforts. Duties include developing and maintaining internal operating policies and procedures related to regulatory and quality affairs for the company. * Ensure that the company is in compliance with FDAs Quality Systems Regulations, GMP's, etc. * Support clinical affairs, performing duties as assigned. Clinical duties may include managing trial documentation, interfacing with CRO to conduct trial and site operations.  

 

 

 

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