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Description
Technical Compliance Analyst II- Hyderabad (Hybrid)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life.
Discover what our 29,000 employees, across 110 countries already know.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health
Job Responsibilities
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
. #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
. We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.
Job summary
The Technical Compliance Analyst II supports the quality and compliance activities within the Information Technology (IT) department. The primary responsibilities will include managing IT's Computer System Validation (CSV) Programs to lead and oversee site validation activities ensuring compliance with internal company validation procedures and industry regulations for validation activities.
The ideal candidate will have knowledge and experience in the area of Good Clinical Practices (GCPs) guidance and applicable clinical regulations, including FDA 21 CFR part 11, as related to developing, implementing, validating, maintaining and supporting assigned computerized systems in order to ensure that operations are implemented and maintained in a compliant state.
Job responsibilities
. 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.
. Provide support for Information Technology's project portfolio within assigned projects, ensuring that technology solutions are classified in accordance with set standards, implemented to support those standards within agreed upon timelines.
. Coordinate assigned 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.
. Serve as subject matter expert in specialized project area to support client and regulatory agency audits and inspections for Information Technology activities.
. Lead compliance efforts for any corrective or preventative actions plans supporting assigned Information Technology solutions.
. Execute harmonization of compliance activities to support mergers, acquisitions and internal expansion of the compliance program.
. 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
. Make recommendations for continued improvement in the area of compliance for Information Technology.
. Perform training in the principles of computerized systems validation for internal personnel.
. Conduct periodic reviews of validation documentation to ensure systems continue to operate in a validated state, and perform impact assessments on planned GxP and Business Critical Change Management requests.
. Perform quality reviews of validation deliverables.
Qualifications
What we're looking for
. Bachelor's Degree in Computer Science or related science field or equivalent.
. Three to five years of relevant experience
. Experience with 21 CFR Part 11 required
. Experience in computer systems validation/software development life cycle approaches.
. Experience inworking ina clinical trials environment, including a comprehensive knowledge of GCP regulations guidelines
. Effective verbal and written communication
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Summary
The Tech Compliance Analyst II plays a key role in ensuring the organization's internal controls comply with Sarbanes-Oxley (SOX) requirements. This position supports all aspects of compliance activities for programs including Sarbanes-Oxley (SOX) and others that require the review of security control performance. - including risk assessment, process documentation, control testing, and issue remediation - while partnering closely with business process owners, IT, and external auditors. The ideal candidate will bring a strong understanding of internal controls, financial reporting processes, and operational risk management.
INC Research/inVentiv Health has become Syneos Health, the only fully integrated end-to-end clinical and commercial solution organization. We are purpose-built for biopharmaceutical acceleration, creating better, smarter, faster ways to help clients navigate an increasingly complex marketplace. Our new business addresses today’s market realities through clinical and commercial sharing expertise and data and insights to meet the needs of emerging and large global biopharmaceutical companies.
Job ID: 137652489
