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Senior Regulatory Affairs Communication Specialist

  • Job reference: 922832
  • Location: Inverness, Highlands
  • Salary: Negotiable
  • Job type: Permanent
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 05/12/2018

Orion group are recruiting a Senior Regulatory Affairs Communication Specialist on behalf of our Multinational Medical Device client, it could be based in Northern Scotland or in Switzerland

This is a Permanent Position

The Senior Regulatory Affairs Communication Specialist will manage the timely and efficient submission and approval process of promotional projects. This includes ensuring that the projects are processed, routed and stored in accordance with all relevant requirements and regulations.

This role is responsible for Advertising and Promotional Copy review, reporting into Global Regulatory Affairs.

Responsibilities:

  • Manage the routing, processing and storage of promotional content and claims submissions to ensure quality and cycle time goals are met.
    • Review claims and copy submissions in the Zinc MAPS Electronic Copy Review System to confirm that the necessary documentation is available, prior to distribution to reviewers.
    • Assist Originators with fulfilling the submission requirements, as needed
    • Inform Copy Review Manager about unresolved issues between copy originators and reviewers to ensure that issues are resolved in a timely manner and changes are implemented as requested
    • Ensure completed, approved submissions match final artwork
    • Identify areas for process improvement and drive implementation

Compliance:

  • Ensure that copy review submissions are stored in alignment with defined standards and documentation requirements
    • Train Copy originators / Users on Copy Clearance process and the Zinc MAPS Electronic Copy Review System (via Conference Calls and WebEx)
    • Develop and maintain training / guidance materials

Metrics:

  • Align target review cycle times/responsiveness goals with Copy Review Manager
    • Work towards efficient review cycle

Requirements

  • Commercial education or University degree
  • Minimum 3 years of work experience (at least 1 year of this time in a regulated environment, e.g. Pharma or Medical Devices)
  • Educational background in Marketing, Communication, Regulatory Affairs, Legal
  • Fluent in English (Knowledge in another European language is beneficial)
  • Accuracy with attention to detail
  • Comfortable with working in multi-disciplinary teams in an international, culturally diverse environment
  • Ability to manage conflict
  • Good project management skills and strong communication skills
  • Comfortable working in a process-driven, regulated environment


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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Senior Regulatory Affairs Specialist
  • Salary Negotiable
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  • Description Orion group are recruiting a Senior Regulatory Affairs Specialist, (Compliance & Sustaining) on behalf of our multinational medical device client based in Northern Scotland This is a Permanent