Post a job
Legal And Compliance Manager

Company:
Star Medical Ireland on behalf of Uniphar
Location:
Dublin, Country: Ireland
Job Type:
full-time, permanent
Job Description

Objective: To protect and safeguard the Irish affiliates commercial interests, reputation and license to operate by working with management and Line of Business (LoB) in identifying, managing and mitigating risks within business ethics, contractual agreements, and compliance with requirements such as general legislation; pharmaceutical regulation; industry codes, internal regulation; and local best practices

Main Duties & Responsibilities

  • Compliance with applicable Business Ethics (BE) and Legal frameworks, industry codes,

pharmaceutical legislation, and internal regulation such as BE Framework, Code of Conduct, and both
local and global Standard Operating Procedures

  • Promotion and embodiment of a BE mindset, communication and consistency in daily affiliate

operations and overall company commercial objectives across departmental functionalities

  • Efficient and methodical compliance and ethical review of all relevant cases, enabling management

and LoB to make merited strategic decisions based on appropriately identified risks.

  • Targeted training of management and LoB in relevant framework e.g IPHA Code and Standard

Operating Procedures relating to compliance and BE.

  • Lead co-ordinator and owner of all internal and external audit preparations related to BE, Compliance

Legal, BE, Compliance Leadership

  • Legal Affairs: Responsible for all legal affairs in the affiliate. Manage and handle claims and

litigations and oversee investigations by the authorities in the affiliate

  • Coaching and Information Supply: In-house advisory and coaching service on BE, compliance and

legal matters.

  • Communication: Providing tools for “setting the tone from the top”. Proactively keep the affiliate

informed of relevant external and internal BE cases that could have an impact on local operations.

  • Risk assessments: Quality in both reactive and proactive measures taken in managing business

ethics and compliance risks. Diligence in providing stakeholders with business ethics and compliance
counsel on risk management in all operations; especially external interactions that will protect
against identified and known BE or compliance risks

  • Awareness-creation: Ensuring that management and LoB maintain high awareness of business ethics

and compliance, and ensuring that stakeholders are aware of their compliance responsibilities.

  • Business Ethics Compliance Framework: Keeping updated with amendments to the framework and

communicating such to relevant stakeholders in a clear and operational manner. Being content
responsible and editor.

  • Risk Management and Counselling: Being the primary liaison for compliance risk management and

providing reliable compliance counsel on both general and specific business ethics and compliance
matters to management and LoB.

  • Training: Coordinating and conducting training sessions on business ethics and compliance, targeted

relevant stakeholders and develop materials suited for such training.

Audit Readiness

  • Group Internal Audits: Lead the preparation for internal and external audits in relation to compliance.
  • Spot checks: Conducting spot checks as per instructed by business area and additionally if needed.
  • Local Due Diligence Responsible (LDDR): Ensure compliant due diligence.

Compliance Business Partner

  • Aligning operations with Business Area: Duly implementing compliance activities as advised by ENW

Head of Legal and Compliance and responsible for implementation of the local Compliance
Programme

  • Work with local management team to devise corrective actions to identified business ethics and

compliance issues, and assist local management in ensuring the right compliance mind-set

  • Ensure up-to-date templates for agreements with HCPs and HCOs
  • PromoMats: Timely and ample review of external communication material that have BE-exposure;

including promotional materials.

  • Expert Directories: Timely and ample review of local HCP/HCO honorariums against local FMV.
  • Local reporting responsible (LRR): Act as local responsible person to pre-notifications from other

affiliates or the company’s headquarters about engagement of local HCPs

  • Training: Evaluation of the relevance and quality of performed training sessions in teams,

departments and management.

  • Grants, Donations & Sponsorships(GDS): Lead G/D/S Committee, review incoming grants, donations

and sponsorships requests and provide counselling from a BE-prospective.

  • Market Research: Coordinating reviews on local Market Research Programmes; herein safety

assessment for contractual arrangements.

  • Competitor Complaints: Handling complaints including acting as the main link to IPHA and outside

counsel (if applicable). Driving the compliance aspects of competitor complaints and providing
stakeholders with counsel on relevant mitigating measures.

  • Meetings and Congress: Provide local compliance advice in relation to international congresses,

cross-border grants, etc., as applicable

  • Local Code: Advise the business on, and be the subject matter expert in, the local code of conduct as well as corporate business ethics requirements
  • Targeted training of management and LoB in relevant framework e.g IPHA Code and Standard

Operating Procedures relating to compliance and BE

  • Conduct or assist in internal investigations Legal Advisor
  • Risk Management: Identify legal risks and other legal trends/developments and share them with the

local management team and/or the Legal Director in the BA, as appropriate

  • Legal Master List (LML): Legislation List Administrator of the LML and Legislation List Monitor for

legislation and guidelines in scope of the Compliance area.

  • Agility: Provide legal support in affiliate key projects, including support to market access and other

strategically important projects

  • Analysing work processes in order to identify measures which will enhance business efficiency in a

legal and compliant manner.

  • Onboarding: Training new employees to the affiliate on an introductory level to matters of

compliance, business ethics, and legal.

  • Local Reporting Responsible (LRR) Being the LRR for Ireland; (not responsible for reporting to local

authorities), reviewing HCP master data and payment data, or responding to pre-notifications outside
the Expert Directories from stakeholders outside the unit (Transfer of Value TOV).

  • Internal Contracts Reviewer: Review and respond to any contract queries raised by the internal team

in relation to contracts raised with vendors and suppliers. Provide advice within areas such as
pharma law, competition law, GDPR, corporate governance, and review of contracts

  • Internal/External Legal Network: Facilitate contact to/support from Legal, as needed and Coordinate

external law firms in line with Global Legal guidelines
Local DPR

  • Act as the local Data Protection Responsible (DPR) in the affiliate (not a DPO role – this role sits with

a function in the company’s headquarters in Denmark)

  • Maintain local personal data overview
  • Actively engage the local organisation to foster a compliance mind-set and understand and follow

compliance requirements

  • Conduct training and provide advice as needed * Support local organisation in assessing risk from personal data processing * Drive and support response to data breaches and data subject requests (support DPO in responding to potential personal data breaches, handle data subject requests in alignment with the DPO, support DPO in interactions with local Data Protection Authorities)

Qualifications

  • Master degree in Health Science or Law
  • Technical Skills
  • Good data management and IT Savvy including
  • computer literacy & key board skills
  • MS Office Suite (Word, Excel, PowerPoint and
  • Adobe InDesign)
  • Digital Marketing Skills

Work experience

  • 2 years in similar role desirable
  • Experience within the fields of Compliance
  • Proven experience in the pharmaceutical industry,
  • for example, knowledge of analysing compliance
  • issues, sales, marketing, medical information,
  • research or training
  • * Experience of reviewing promotional and non-
  • promotional material

Personal qualifications / key competencies

  • Stakeholder management
  • Business and Industry understanding
  • Quality mind-set, focus on detail, coordination
  • and time management skills
  • Compliance Expertise
  • Risk Analysis, Assessment & Action
  • Driving Compliance Programme + change
  • management
  • Communicating with Impact
  • Planning & organising

Job Types: Full-time, Permanent

Work remotely:

  • Temporarily due to COVID-19
Job Settings
Number of jobs: 1 hires
Information about the advertiser
Company: Star Medical Ireland on behalf of Uniphar
Company size: 1-49
Contact: NA