Medical Governance and Ethics Manager

Medical Governance & Ethics Manager Bulgaria

We are seeking aMedical Governance & Ethics Managerto work in close partnership with crossfunctional teams to understand stakeholder needs and delivermeasurable valuetoAstraZeneca.

In this role you will provide independent unbiased guidanceto Commercial and Medical teams supporting the planning review and development ofpromotional and nonpromotionalmaterials and activities forHealthcare ProfessionalsHealthcare Professional OrganizationsGovernment OfficialsCommunity Organizations and thegeneral public.

You will also act as aNominated Signatory ensuring compliant approval of materials and activities in line with applicable codes and internal policies and provideMedical Information (MI) supportby delivering accurate balanced and timely scientific responses and insights to inform content training and process improvements. Your expertise will help embed ethical standards regulatory compliance and scientific integrity across our external engagements and communications.

What You Will Do

• Build and maintain positive working relationship across TAs in support of internal processes and practices.

• Act as an advisor on the application of internal/external code of practices (internal policies EU and EPPIA requirements related to corporate compliance)

• Act as Nominated Signatory business units and for non-brand and above brand material and activities as per global and local policies and SOPs.

• Maintain a broad knowledge of ONCO/RIA/CVRM/V&I/RD brand data messaging and undertakings and integrate the detailed input of Medical Advisors on scientific content and Regulatory for alignment with label into final recommendations and guidance and to inform sign-off as appropriate.

• Promote best practice by sharing successes and by helping to identify/resolve issues with Brand and Scientific Affairs teams

• Collaborate cross-functionally supporting the team with advice on internal review/approval processes (including material review pre-market authorization Advisory Board Governance)

• Support the Fair Market Value requests via the Nominated Signatory platform and Fair Market Value assessments through assisting verification of qualification licence validity and application of the FMV guidance when requested

• Support Medical Affairs First Line Monitoring as well as internal audits risk assessments and other Medical Ethics needs

• Support Patient Assistance Program through compliance review and documentation.

• Lead country MI to deliver accurate balanced timely responses to unsolicited HCP/public inquiries in line with local regulations and global standards.

• Own the country MI SOP maintain updates and ensure audit readiness.

• Deliver regular MI training (onboarding and refreshers) on processes triage approved responses and PV/reporting requirements.

• Oversee MI vendors and channels including quality monitoring.

• Act as a role model and ensure ethical/professional behaviour

• Support training and communication in relevant SOPs and local market ethical standards and practice including maintenance and regular update of local procedures related to NS function

• Authorise the release of promotional and related materials in a personal professional capacity and on behalf of the Marketing Company.

• Ensure that the company processes and standards relating to review and approval of promotional and related materials are adequate to enable the NS to authorise release of materials.

• Ensure that the company processes and standards relating to review and approval of meetings and related materials are adequate to enable the NS to authorise meetings

• Take a lead in managing complaints to and from the company relating to Sales and Marketing Practices

• Support the MC in the provision of training and testing with respect to sales and marketing practices

• Take a lead on behalf of the MC in managing complaints to and from the company relating to Sales and Marketing Practices

• Ensure the reporting of all marketing code compliance issues to the compliance and ensure appropriate documentation is maintained

• Report all breaches of marketing and sales codes and regulations as required

Knowledge Skills & Experience:

• Bachelors degree required; field of study must be Medicine (MD)Pharmacy orVeterinary Medicine

• Minimum 3 years of experience in quality compliance regulatory medical or commercialfunctions within a regulated environment (pharmaceuticals clinical research or medical devices).

• Excellent written and verbal communication skills including the ability to manage difficult or sensitive communications with clarity tact and professionalism.

• Experience with computer systems and a computer network is essential.

• Advanced English for reading scientific articles

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.