Compliance Operations

3 weeks ago

Burlington, Canada BI Canada Ltd Full time

**The Position**:
Serve as a strategic business partner to core functions in creating awareness, understanding and acceptance of Legal & Compliance requirements to ensure that the company's culture of compliance is a natural element of day-to-day business.

Develop and foster strong working relationships across the departments in the business to lead the organization in operationalizing compliance requirements.
Accountable for leading the efficient and appropriate facilitation of the Non-Trial Activity (NTA) review and approval process, including consulting with business partners on NTA eligibility.

**Responsibilities**:
1) Be an early adopter of Compliance within the HP Canadian organization, lead the adaptation of cross functional department processes and adjust materials to best fit department workflows; drive operationalization and use in daily activities within business.

a) Work with departments across the organization to determine the strategy for development and implementation of compliance related controls, including Standard Operating Procedures, Frequently Asked Questions, process flows, decision trees, analytical frameworks and automated systems (if applicable).

b) Work with departments to lead the implementation of the above and the deployment of live and web-based training to employees, consultants and other third parties as applicable.

c) Subject matter expert for compliance related workflows within the organization and first point of contact for all compliance related workflow questions
- Transparency and Disclosure (T&D) lead for business for cross border engagements.
- Work with Compliance and business process owners to:
a) coordinate all internal auditing and monitoring of document production requirements across the organization and the timely resolution of audit findings and related remediation plans

b) raise compliance awareness (e.g., communication at Nat'l Business meetings, leading Compliance Days, etc.)
- Act as business owner and primary point of contact for potential project owners for the NTA review and approval process towards all organizational stakeholders within the Regional Operating Unit((R)OPU) functions.
- Drive the implementation and the facilitation of the NTA review and approval process in a compliant and sustainable manner.
- Implement local NTA review and approval process and ensure process compliance according to global SOP and local legal requirements.
- Lead the classification, review and approval of NTA projects along with stakeholders (locally and globally)
- Consult with the global NTA manager as needed; lead the review and approval of high impact local NTA proposals with the corporate NTA Steering body
- Consult business NTA project owners, provide guidance and share expertise on best practice ways of working in close collaboration with global governance team
- Drive NTA process flow and consultation with Medicine, Pharmacovigilance (PV) and other functions as required
- Ensure and facilitate appropriate local NTA process trainings
- Track process performance according to defined metrics Key Performance Indicators (KPI).
- Monitor customer satisfaction to support process optimization.
- Actively participate in the global network of local NTA managers and Corrective Action Prevention Action (CAPA) master training.
- Support PV inspection and audit from NTA process and record keeping perspective.
- Ensure that NTA /PV/ Medical Review (MR) process is adhered
- Support General Data Protection Regulation (GDPR) procedure / contracts
- Be the Human Pharmaceuticals (HP) PV commercial lead / contact point

This position is based in the Burlington, Ontario office located at 5180 South Service Road and is **flexible.**
Employees in flexible roles are required to be at the office a minimum of 50% of the time each month and must report to the office when requested and required by their Manager/Department.

**Requirements**:

- Bachelor’s degree or higher, with experience in compliance related activities preferred
- 5+ years professional experience, 3-5 years demonstrated experience in healthcare compliance within a Pharmaceutical or Medical Device company
- Strong attention to detail and excellent Project Management skills. Prefer accredited project management training
- Strong leadership and interpersonal skills to drive change; skills and ability to build strong relationships with peers and stakeholders and influence without authority
- Organized with systematic approach to prioritization and operational excellence.
- Has a demonstrated can-do attitude to find solutions with strong problem solving and issue resolution skills
- Able to work independently and deliver results with mínimal supervision
- Computer skills (i.e. MS Office,Outlook, PowerPoint, Word, Excel)
- Ability to work collaboratively with internal and external customers;
- Adapts to changing conditions and drives accountability and results

**Total Rewards**:
We offer a competitive salary, generous

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