Compliance/Centralization Team Manager - Final Signatory

Recruiter
SRG Clinical
Location
Bedfordshire
Posted
10 Oct 2018
Closes
17 Oct 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
The team is made up of promotional compliance specialists and administrative support, which is responsible for review and approval of in-field team interactions with HCPs and HCOs, including high-cost in-field meetings as well as the Grants and Donations process for the UK Affiliate. Drive industry leading meetings and engagements between my client and the Healthcare Community, ensuring appropriate governance and policies are implemented and adhered to, and driving a culture of compliance.

Key responsibilities


Manage the Compliance/Centralisation Team processes for review and approval of promotional and non-promotional activities and materials, ensuring that these arrangements are in line with the Association of British Pharmaceutical Industry (ABPI) standards, the Medicines and Healthcare Regulatory Agency (MHRA) blue guide for advertising and promotion and all applicable international Codes of Practice (EFPIA, IFPMA, and respective National Codes and National Regulatory Bodies) at all times



Provide guidance and leadership to line reports for all activities within the defined scope of the team within agreed timelines and according to company policy & process
Support timely, accurate review and approval of materials in accordance with the relevant Codes of Practice working in partnership with the Promotional Affairs Department
Ensure that ABPI transparency reporting requirements are met according to the internal process with regards to Centralisation Team processes
Drive compliance and continuous improvement in the field and at head office with respect to Healthcare Professional (HCO) and Healthcare Organisation (HCO) interactions, including speaker meetings, sponsorship meetings, and grants and donations
Work to optimise centralisation team systems and process to maximize efficiency and effectiveness
Provide guidance and leadership on internal policy and process review project(s)
Develop existing SOPs and Policies for iComply SPC system, Grants and Donations, and Commercial Interactions with HCPs and HCOs and take ownership of these.
Input to Compliance Steering Committee with non-conformance records originating from Centralisation Team processes, and assist with investigation to any breaches of Code or internal policy originating from these processes
Attend Transparency Committee meetings and input to improvement and compliance requirements
Provide guidance, and to identify opportunities to share insights to support business development opportunities/product launches and contribute to the development of marketing campaigns and other strategic opportunities
Develop training program for Centralisation Team members in collaboration with the Learning department


Qualifications & Competencies


Higher professional qualification in a scientific or business discipline
Strong leadership skills, ideally with line management experience
Experience in Promotional Copy Review Approval highly desirable
Strong understanding of the ABPI Code of Practice and experience of implementing robustly
Experience of SOP and process development and improvement.
Experience of compliance process management, investigation and reporting.
Demonstrated ability to consistently comply with relevant internal policies and procedures, and to generate a culture of compliance among direct reports and other cross-functional stakeholders.
Strong organisation and project management skills.
Versatile and flexible.
Ability to network both within and outside the organisation, and work across a matrix.
Excellent verbal and written communication skills and experience in developing and implementing strong communication and engagement plans.


Please contact Gary Montgomery Via email at or can call me 07789878300 on if you would like to know more about this opportunity. Unfortunately, I cannot consider candidates outside the EU

Brand Teams, Good Clinical Practice, FDA, MHRA, Training, SOP, Medical, Learning Partner,ABPI, Compliance,(ABPI) standards,promotional and non-promotional

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