eNewsletter Signup
Miles
Km80.5

Specialist/Sr. Specialist Global Regulatory Information and eDocumentation (308-419)

ARIAD Pharmaceuticals, Inc.

Apply
E-Mail to a Friend Add to Job Folder View All Jobs Back to Search Results Share
Location: Cambridge, MA Posted Date: 4/12/2013 Position Type: Full time Job Code: 308 Required Education: Other Areas of Expertise Desired: Administration

Description

ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Summary:

This position provides R&D electronic document management coordination & services (templates, formatting, proof-reading, publishing, and archiving) for R&D regulatory submission documents and the data source documents that support them by executing the business implementation and life cycle management of electronic document management systems (EDMS) and associated business processes. This position also executes and maintains processes for Regulatory Affair’s global submissions, correspondences, and commitments in accordance with Good Documentation Practices.

Duties and Responsibilities:

- Maintain and administer the global regulatory information and documentation databases
-  Electronically publish regulatory submission documents to industry and company defined standards (INDs, NDAs, CTA, MAA, eCTD, NeES, etc.)
-  Electronically publish regulatory submissions using the eCTD software suite to industry and company defined standards
-  Maintain ClinTrials.gov
-  Adhere to assigned timelines for global regulatory submissions
-  Supports Medical Writing in the tracking, preparation, and finalization of Clinical Study Reports within the enterprise document management system, and liaison with Clinical Quality Assurance (CQA) to process the Clinical Study Reports through theCQA approval process
-  Serve as a primary user and business expert of the eCTD software suite
-  Provide business user support for the workflow of regulatory submission documents through the document management system
-  Execute assigned activities for eCTD life-cycle document management within the document management system and the eCTD software suite
-  Support maintenance of Trial Master Files in electronic format
-  Execute, adhere to, and recommend improvements to Regulatory Operations work practices and guidelines
-  Execute Regulatory Operation’s quality assurance processes on electronic submission documents and the validation processes for eCTD submissions as directed
-  Maintain the eCTD word processing templates and train users on their functionality
-  Maintain the eCTD viewing system docbase archives/regulatory submission archives
-  Execute computer system validation test scripts as directed
-  Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
-  Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Requirements


- 1+/3+ years in the pharmaceutical industry Regulatory Operations arena is required
-  1+/3+ years of hands on experience with an eCTD Software System is required
-  1+/3+ years of advanced user skills using Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory submission documents are required
-  1+/3+ year of user experience within an enterprise Document Management System is required
-  1+/3+ year user experience with Documentum based products is required
-  Knowledge of the industry standards for desktop publishing regulatory submission documents, including Case Report Forms, to eCTD readiness is desired
-  Experience publishing Clinical Study Reports to ICH E3 standards for use in eCTDs is desired
-  Experience on a cross-disciplinary Regulatory Submission Team from the Regulatory Operations services perspective is desired
-  Experience with Microsoft Excel and Microsoft Project is desired
-  General knowledge of Computer System Life Cycle Management techniques is desired
-  Strong commitment to business ethics
-  Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.
-  BA/BS degree is preferred

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.
Apply
E-Mail to a Friend Add to Job Folder



By applying to/saving a job using , you are agreeing to comply with and be subject to the Terms of Use for use of our website. To use our website, you must agree with the Terms of Use and both meet and comply with their provisions.

ADVERTISEMENTS