Healthcare Compliance Specialist

hace 1 semana

Madrid, España Internetwork Expert A tiempo completo

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a Healthcare Compliance Specialist to join Norgine in our Consumer Healthcare division. The person holding this position will report to the Healthcare Compliance Lead.

The core responsibility of the Healthcare Compliance Specialist will be developing, implementing, overseeing, and managing consumer compliance activities, as well as establishing standards and monitoring governance across Norgine, including relevant stakeholders, systems, and linked committees where in place. This role requires a thorough understanding of European healthcare regulations, industry standards, and the ability to manage compliance risks in a dynamic environment to ensure our operations meet the highest standards of compliance and regulatory adherence in the Consumer Health area.

KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

  1. Compliance Programme Development and Implementation:
    1. Develop, implement, and maintain comprehensive compliance programmes related to consumer health by establishing relevant and easy to use internal global standards, policies, and procedures.
    2. Ensure compliance with EU and local regulations, including advertising, labelling, and promotional activities.
    3. Ensure adherence to relevant Consumer Health Codes of Practice and other relevant national codes of practice or regulations across Norgine territories.
    4. Support and manage relevant global electronic systems related to Healthcare Compliance for effective use with consumer health, developing and maintaining relevant processes and workflows, working in partnership with Compliance Systems Executive and Business System Owner as well as relevant stakeholders across the company.
    5. Develop, report, check, manage, and monitor KPIs where needed.
  2. Regulatory Monitoring and Reporting:
    1. Conduct horizon scanning with respect to changes in relevant regulations across territories, assess their impact on the company, align with stakeholders, and update compliance programmes accordingly.
    2. Stay current with Consumer Health Codes of Practice and ensure company global controlled documents align with these standards.
    3. Prepare and submit compliance reports as required.
    4. Attend relevant forum and committee meetings.
  3. Training and Education:
    1. Promote, develop, and deliver compliance training programmes to educate and increase compliance.
    2. Ensure all staff are aware of compliance requirements, best practices, and the specific Consumer Health Codes of Practice relevant to their region.
    3. Manage Consumer Healthcare Compliance related information and repository of relevant documents, including the maintenance and content of SharePoint sites as appropriate.
    4. Monitor and address Consumer Healthcare Compliance related issues and complaints.
    5. Identify and drive improvements in compliance and Healthcare Compliance related activities and processes.
  4. Risk Management:
    1. Identify and assess compliance risks related to consumer health products.
    2. Support with risk mitigation strategies.
    3. Conduct regular compliance risk assessments and audits to ensure adherence to standards, regulations, and industry codes.
  5. Audit and Inspection Coordination:
    1. Coordinate and manage audits and inspections as required.
    2. Ensure timely and effective resolution of any compliance issues identified during audits or inspections.
    3. Prepare for and manage interactions with regulatory bodies regarding Consumer Health Codes of Practice where applicable.
  6. Collaboration and Communication:
    1. Work closely with legal, regulatory, marketing, and other departments to ensure integrated compliance efforts.
    2. Act as a liaison between the company and regulatory authorities, including agencies overseeing Consumer Health Codes of Practice.
    3. Contribute to or lead consumer healthcare compliance projects as required.
  7. Documentation and Record-Keeping:
    1. Maintain comprehensive records of compliance activities, investigations, and resolutions.
    2. Ensure documentation meets regulatory standards, company policies, and industry codes of practice.
  8. Ethics and Integrity:
    1. Promote a culture of ethics and integrity within the organisation.
    2. Address and resolve any compliance-related ethical issues.

Minimum Requirements:

  1. Minimum of 3 years of experience in healthcare compliance within the consumer health industry, ideally with experience in more than one country.
  2. In-depth knowledge of European consumer healthcare regulations and compliance requirements.
  3. Familiarity with pharmaceutical advertising, promotional regulations, and Consumer Health Codes of Practice.
  4. Proven ability to develop and implement effective compliance programmes.
  5. Excellent communication and training skills.
  6. Strong analytical and problem-solving abilities.
  7. Experience with digital health compliance.
  8. Experienced in process mapping, design, authoring, and review of processes (Policies, Standard Operating Procedures, and Work Instructions), with understanding of Lean 6 Sigma an advantage.
  9. Ability to think strategically and assess the extent of compliance risks, manage/escalate in a proportionate manner, including complex situations in which interpretation of Codes is required.
  10. Display emotional intelligence and diplomacy to work with senior management.
  11. Ability to lead projects and implement formal change management.

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you’ll have with Norgine, then apply here.

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