|State ||New Jersey [NJ]|
|Title ||Validation Specialist (CFR 21 Part 11)|
|Job ID ||64697|
You re driven, resourceful, and above all else - remarkably smart.
You love a good challenge. You are the first to roll up your sleeves and work with relentless energy until you solve the unsolvable, beat the unbeatable and you always come out on top. Passable doesn t cut it you ve got fire in your belly to learn more, do more and be more. For you, the sweetest success is shared success and you re known for your good nature. You ll fit right in at inVentiv Health where we surround ourselves with the most talented and agile professionals in the industry, but we check our egos at the door.
Why inVentiv Health? Join a groundbreaking network of more than 15,000 employees in 110 offices worldwide with the ability to service clients in over 90 countries. Take part in offering world-class therapeutic expertise to leading biopharmaceutical companies so they can focus on what they do best - prevent and treat disease. You ll provide the brilliant ideas, valuable insight and relentless energy that drive biopharma products from lab to life. In the past five years, inVentiv Health has helped to develop or commercialize 81% of novel new drugs approved by the FDA and 70% of products granted marketing authorization by the EMA.
Here, there s no shortage of challenging work, learning and opportunities. Because we offer many services to varied clients, our knowledgeable professionals gain experience across a large section of the industry. Our client roster consists of more than 550 leading Pharmaceutical, Biotech, Life Sciences and Healthcare payer companies and all 20 of the largest global biopharmaceutical companies.
- Provide support for Business Technology s project portfolio ensuring that technology solutions are classified in accordance with set standards, implemented to support those standards within agreed upon frameworks and timelines.
- Participate in evaluating and purchasing new technology solutions systems from a compliance and risk perspective
- Responsible for developing, implementing, validating, maintaining, supporting computerized systems in order to ensure that operations are implemented and maintained in a compliant state.
- Manage and/or coordinate the writing and execution of validation protocols, specifications, change controls and/or scripts related to software, instruments and/or equipment according to the organization's compliance requirements and industry regulations.
- Coordinate project deliverables with external consultants and suppliers concerning the implementation, validation, support and maintenance to ensure these activities are completed in alignment with standard compliance principles.
- Support external client and regulatory agency audits, providing documentation and support in support of Business Technology activities.
- Lead compliance efforts for any corrective or preventative actions plans supporting assigned Business Technology solutions.
- Review/harmonize the compliance work processes and those of other divisions when applicable
- Act as a compliance resource expert to other groups
- Assist internal clients with requests and problem resolution, participate in the maintenance of documentation and make recommendations for greater effectiveness in functional area of compliance
This person will perform the validation of pharma covigelence, clinical data managment and clinical trial data. The ideal candidate will have Oracle Argus (safety), Oracle Inform (clinical data) and SAS (able to validate or qualify). Knowledge of CFR 21 Part 11 is needed. Can prove the system works as expected and consistently. Can etarxt and write documents to be reviewed by regulatory and client auditors.
Along with demonstrated initiative, uncompromised integrity and a results-oriented mindset, the ideal candidate has:
- Bachelor's Degree in Computer Science or related science field or equivalent. In lieu of degree nine years (total) relevant experience will be considered
- Six years professional regulatory compliance experience
- Knowledge of CFR 21 Part 11
- Understanding of current and emerging regulations and impact on technologies
- Effective verbal and written communication
Full inVentiv Health benefits which include:
- Competitive compensation and bonus
- Generous paid time off and company paid holidays
- Comprehensive medical, dental, and vision package
- Matching 401K
- Dedicated training and support
- Tuition reimbursement
- Referral bonuses and other personalized quality of life conveniences
Make your work matter everywhere. Be a driving force in a rapidly evolving healthcare industry.
inVentiv Health is an affirmative action/equal opportunity employer (Minorities/Females/Vet/Disabled)
|Position Type/Category ||Information Technology|
|Recruiting Area ||Corporate Direct|
|Minimum Education Level ||Bachelor's Degree|
|Employment/Job Type ||Full Time|