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Manager, Global Regulatory Information and eDocumentation (GRID) (319-419)

ARIAD Pharmaceuticals, Inc.

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Location: Cambridge, MA Posted Date: 4/30/2013 Position Type: Full time Job Code: 319 Salary: DOE Required Education: Bachelors Degree Areas of Expertise Desired: Information Systems

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

Duties and Responsibilities:

- Manage the maintenance and business administration of global regulatory information management systems
- Participate on cross-functional teams to execute computer system validation of Regulatory Information Management Systems and EDMS
- Develop and deliver user community training for Regulatory Information Management Systems and EDMS
- Provide expertise and support to the global user community for Regulatory Information Management Systems and EDMS
- Serve as an expert support resource and trainer in R&D Document Management System and Regulatory Information Management System
- Manage and execute the electronic publishing of regulatory submission documents to industry and company defined standards (INDs, NDAs, CTA, MAA, eCTD, NeES, etc.)
- Manage, track, and execute the production of global regulatory submissions
- Support 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 the CQA approval process
- Support maintenance of Trial Master Files in electronic format
- Participate on cross functional teams to develop PPP (Policy, Procedure, and Process) in accordance with Good Documentation Practices
- Analyze, author, and continuously improve Regulatory Operations work practices and guidelines
- Stay current on current industry trends relevant to global electronic submissions
- 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
- Strong commitment to business ethics
- Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

Requirements




- 5+/7+ years in the pharmaceutical industry Regulatory Operations arena are required
- 5+/7+ years of hands on experience with an eCTD Software are required
- 5+/7+ years of advanced user skills using Microsoft Word and Adobe Acrobat desktop publishing techniques for regulatory submission documents are required
- 5+/7+ years of user experience within an enterprise Document Management System are required
- Regulatory Submission team timeline management experience is required
- Experience with Documentum based FirstDoc is highly desirable
- Experience developing PPP (Policy, Procedure, and Process) from the Regulatory Operations perspective is required
- Experience developing and delivering classroom training for Regulatory Operations processes and systems is highly desirable
- Knowledge of the industry standards for desktop publishing or regulatory submission documents to eCTD readiness is required
- Experience publishing Clinical Study Reports to ICH E3 standards for use in eCTDs is required
- Experience on a cross-disciplinary Regulatory Submission Team from the Regulatory Operations services perspective is required
- General knowledge of Computer System Life Cycle Management techniques is desired
- 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.
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