Compliance Officer - Anoka, IN, United States - Skyline Solutions

James Miller

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James Miller

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Freelance
Description

Job Title:
Legal, Audit & Compliance Specialist


Location:
Anoka, IN


Posting Date: 02/29/2024


Workplace:
Neu-Isenburg (Hessen), hybrid work model


Employment Type:
Full-time, permanent


Job ID: 1954


Role Description:


Your Role:


  • Point of contact, advisor, and decisionmaker for questions regarding scientific information and promotion of pharmaceutical products according to the German Medicines Act (HWG) in pharmaceutical sales
  • Support with expert knowledge and representation of the company in compliance matters internally and externally
  • Processing, evaluation, approval, and documentation of sales, marketing, and scientific activities in accordance with applicable laws, regulations, and codes
  • Documentation of deviations and risks, as well as creation, adaptation, review, and approval of work instructions (SOPs) and documentation of compliance with relevant processes
  • Close collaboration with the marketing, medical, sales, and market access teams with independent reporting line to the management
  • Interface to the global compliance structure
  • Implementation of global guidelines and integration into local work and approval processes
  • Training of all employees and onboarding training for new employees on applicable compliance guidelines and workflows
  • Implementation and monitoring of a 2level monitoring system to ensure compliance with guidelines
  • Preparation and execution of internal audits and development and supervision of followup measures
  • Support and advice to the management in compliancerelated areas
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