Specialist, Compliance & Risk Management

Job Description

The Position

The Specialist of Compliance & Risk Management will be responsible for the compliance aspects of computerized systems and supporting infrastructure to ensure compliance with company policies, procedures, and regulatory expectations.

The Specialist of Compliance & Risk Management is responsible for supporting the organization’s compliance with the Sarbanes-Oxley Act by evaluating and documenting IT General Controls (ITGC) and related processes. This role works closely with IT, Internal Audit, and external auditors to ensure the effectiveness of controls over financial reporting.

The Specialist of Compliance & Risk Management must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Responsibilities

The Specialist will manage the change management to ensure compliance.

Ensure that the SOX ITGC Controls were identified and addressed for the deployment / update, working in partnership with other ESQ&C areas.

Perform risk assessments and identify key ITGCs related to access management, change management, and IT operations.

Assist in the design, implementation, and documentation of IT controls.

Collaborate with control owners to remediate deficiencies and improve control effectiveness.

Support internal and external audit teams during SOX audits.

Monitor changes in IT systems and processes that may impact SOX compliance.

Provide training and guidance on SOX compliance requirements.

Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.

Required Education, Experience, and Skills

Bachelor's degree.  Preferably Information Systems, Computer Science, Accounting or equivalent.

Preferable Professional certifications such as CSOPTM or equivalent

Fluent English Speaker

Hands-on experience and understanding of systems supporting pharmaceutical companies

At least 3 years of experience IT audit, SOX 404 compliance, or IT risk management.

Familiarity with frameworks such as COBIT, NIST, or ISO 27001.

Strong understanding of ITGCs and their role in financial reporting.

Good understanding of the current pharmaceutical industry and applicable regulations (FDA / EU / ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.

Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation / compliance.

Familiarity or practical experience in the implementation of systems in a pharmaceutical company

Limited supervision required in day-to-day activities.

Excellent analytical, communication, and documentation skills.

Preferred Education, Experience, and Skills

Operate as part of a self-directed team in carrying out day to day functions and assigning priorities

Good understanding of applicable Standards related to computerized systems development, implementation & Operations.

Business engagement skills, with ability to collaborate with both technical and non-technical roles.

Multi-lingual capabilities preferred.

Experience supporting regulatory inspections.

Excellent oral and written communication skills including persuading others and developing cross functional relationships.

Analytical problem-solving skills applied to issue identification and resolution.

Listening, integrating diverse perspectives, adds value to the achievement of team goals.

Timely decision making.

Project management skills combined with a since of urgency and a proven history producing quality deliverables.

Ability to respond to changing priorities.

Inclusion behaviors.

Secondary Job Description

Who We Are :

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear : A better and healthier every day for every woman.

As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Annualized Salary Range

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note : Pay ranges are specific to local market and therefore vary from country to country.

Employee Status : Regular

Relocation : No relocation

VISA Sponsorship :

Travel Requirements : Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites

Flexible Work Arrangements :

Shift :

Valid Driving License :

Hazardous Material(s) :

Number of Openings :