Regulatory Affairs Manager Stemgent, Inc.
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As a leading provider of value-enhancing human tissue-based solutions to healthcare organizations (both therapeutic and diagnostic), StemgentAsterand (www.asterand.com) is poised to contribute to the transformation of drug discovery and the ushering in of personalized healthcare.
The Regulatory Affairs Manager is responsible for managing all aspects of Asterand?s documentation related to Independent Ethical Committee (IECs) and Institutional Review Board (IRB) submissions and renewals relating to Asterand?s human tissue collection sites across the world. Areas of responsibility include: reviewing, and on occasions revising, Protocols and Informed Consent Forms (ICFs), preparing documentation for new and existing donor sites and submitting these for IRB review, and monitoring and controlling IRB approval status of collection sites. As part of the Strategic Alliances Department, this position is responsible for ensuring that that human tissue samples received from all donor sites meet the ethical requirements for use by Asterand and its customers.
Asterand sets high standards in ethics; the VP of Strategic Alliances must ensure compliance through a broad network of tissue supply sites and comply with many complex and varying governments and government regulations throughout the world. This position reports directly to the VP Strategic Alliances and is key to Asterand?s success in maintaining this compliance.
POSITION DUTIES AND RESPONSIBILTIES:
Review and revise Protocols and ICFs for collection of human tissue samples in hospitals and clinics across the world. Ensure that protocols and ICFs submitted to these bodies meet the requirements necessary to ensure rapid approval
Provide appropriate IRB and other regulatory documents to support development of new tissue supply sites. Ensure suitability and acceptability of documentation for submission to relevant IRB/IECs
Review IRB/IEC approval documents to ensure that documentation received from sites following approval or renewal by IRB/IECs meets Asterand?s active donor site requirements
Submit and review translations of regulatory documents from existing and new sites and ensure that the resulting translations are consistent with the original documentation submitted
Review and revise existing Asterand IRB documentation to maintain current and ensure that any changes in regulations are reflected in the IRB/IEC documentation relating to Asterand tissue supply sites
Monitor status of IRB approvals, renewals etc of existing tissue collection sites and ensure that approvals for existing sites remain current.
Maintain donor site regulatory files to ensure that files are kept up to date and suitable for inspection by auditors from customers and regulatory bodies such as ISO and CAP
Write and review regulatory SOPs. Review and revise existing SOPs relating to ethics and regulation and revise where necessary
Work with Quality Assurance to ensure that all protocols/ICFs are current and controlled for internal and external use
Define and maintain Strategic Alliances regulatory metrics for management review.
Maintain a watch for changes in government and other regulations for collection of human tissue samples to ensure that Asterand?s knowledge and understanding of this constantly changing area remains current
MINIMUM EXPERIENCE AND/OR EDUCATION REQUIRED:
Experience in an ethical / regulatory environment, e.g. in clinical trials, healthcare, etc
Knowledge of ICH GCP and CFRs pertaining to clinical studies
Knowledge of government structure, regulatory requirements and ethical regulations pertaining to collection of human tissue samples in countries located in North, Central and South America, Europe, and/or Asia
Global cultural knowledge or experience of countries in North, Central and South America, Europe, or Asia
Bachelor's Degree in science related field or equivalent work experience
Certification as a Clinical Research Coordinator (CCRC) or in Clinical Research Administration (CCRA)
Experience in scientific or healthcare environment, e.g. academic research, medical institution, clinical trials, medical devices, biotechnology, or pharmaceutical industry
Knowledge of Academic institutions and public or private companies working with human tissue throughout the world
Proficient in Microsoft Office products (Word, Excel, PowerPoint)
Excellent written and verbal communication skills
Good organizational skills and ability to prioritize tasks
Good attention to detail
Excellent leadership skills, with the ability to communicate at all levels within an organization
Excellent team player that is able to work within tight deadlines and to take responsibility for getting the job done well and on time.
Strong interpersonal skills including ability to communicate effectively and influence others
Independent and assertive nature
Ability to interact with medical and scientific professionals in a global setting
Typical office environment
Occasionally required to work evenings, weekends
Pleasant working environment
The job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by the employee. As the needs of the business change rapidly this role will change accordingly, therefore this document should be viewed as guidelines, which are subject to change.
Asterand is an Equal Opportunity Employer (EOE); all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, or national origin.
||790 Memorial Drive |
Cambridge, MA 02139
THIS JOB HAS EXPIRED