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Within Bayer, we're changing the way we work— for higher productivity, faster innovation, and better results. We call it Dynamic Shared Ownership (DSO). Learn more about what DSO will mean for you in your new role here https://www.bayer.com/en/strategy/strategy

Senior Medical Governance Officer 

The role serves to protect the interests of patients and the public, ensuring that Bayer's promotional and non-promotional activities and materials relating to prescription only medicines are carried out in accordance with all relevant legislation and guidelines. These include (but are not limited to) EU directives, UK Medicines Law, the ABPI Code of Practice, MHRA guidelines for the advertising and promotion of medicines in the UK, Advertising Standards Authority (ASA) and company Standard Operating Procedures (SOPs). 

In this role, you will support the implementation and ongoing continual improvement of our compliance programme, ensuring alignment with the seven core elements of an effective compliance framework; including establishing and maintaining written policies and procedures, supporting the code compliance committee, delivering effective training and education, fostering open lines of communication, conducting internal monitoring and auditing (self-inspection), enforcing standards through well-publicized disciplinary guidelines, and responding promptly to detected offenses with appropriate corrective actions.
Additionally, you will support Medical Information activities, ensuring accurate and timely dissemination of medical information in compliance with regulatory standards.

TASKS AND RESPONSIBILITIES
•    Effectively conduct activities related to the ‘Core Elements of an Effective Compliance Program’.
•    Responsible for ensuring the development and maintenance of accurate ABPI Code of Practice related Quality System Documents (QSDs) for the UK.
•    Conduct activities related to the UK Local SOP Responsible Person (LSRP) role, overseeing the update and maintenance of all UK QSDs and to represent the UK Medical Department on the topic of UK QSDs during potential internal and external audits and inspections.
•    Be a key member of internal decision-making groups and committees i.e Donations and Grants Committee, Joint Working Collaborative Working Committee.
•    Create and implement highly effective training and validation on the requirements and application of the ABPI Code of Practice and the Medical Governance departments SOPs.
•    Effectively communicate to all stakeholders when there are changes to legislation and guidance, or code updates and case rulings that could have an impact on Bayer pharma policies, processes.
•    Be responsible for the completion of regular process checks for both Head Office and Field Force activities, including the identification of corrective and preventative actions (CAPAs) and overseeing and their documenting and completion.
•    Collaborate with cross-functional Bayer colleagues to provide expertise and advice regarding the ABPI Code of Practice and related Bayer QSDs.
•    Support and provide cover for local Medical Information related activities for the UK and Ireland, including responding to Medical Information enquiries (when required), examination of local Medical Information responses, and conducting Quality Control checks of Medical Information responses to ensure are carried out in accordance with relevant requirements.
•    Undertake additional activities, as deemed necessary for the role.

Key Working Relation:
•    Effectively collaborate with the Strategic Expert, Medical Governance to review work in progress, prioritize demands, identify issues of operational importance and identify solutions to enable timely execution of business activities.
•    Within the Company: Colleagues from the cross-functional pharmaceutical division, country platform functions and the global LQSD and Medical Information team(s).
•    Outside the Company: Healthcare Professionals and Other Relevant Decision Makers (ORDMs), Prescriptions Medicines Code of Practice Authority (PMCPA), Regulators (MHRA), Compliance Consultants and third-party service providers.

WHO YOU ARE
•    UK life sciences degree level or equivalent qualification, as minimum.
•    Detailed knowledge of the ABPI Code of Practice and MHRA guidelines for promotion of medicines.
•    Highly experienced within a Governance or Compliance role in the Pharmaceutical Industry.
•    Demonstrated ability to proactively manage and adapt to shifting priorities, effectively balancing multiple tasks while fostering strong partnerships across business functions to achieve strategic objectives.
•    Experienced in SOP writing and management, with excellent attention to detail.
•    Demonstrated ability to effectively plan and deliver engaging training events, coupled with confidence in presenting to large audiences.
You will attend the office in Reading once a week (Tuesday) for the teams meeting. We therefore prefer someone who lives max 1 hour away from reading.

Be You at Bayer where you have the opportunity to be part of a culture influencing Health for all and Hunger for none.  
To achieve our vision we see reward for all our employees as incredibly important, so here are some of the benefits you will receive as a Bayer employee.   

WHAT WE OFFER:

• Competitive compensation package consisting of an attractive base salary and annual bonus.  
• Individual bonus can also be granted for top performance awards.
• 28 days annual leave plus bank holidays
• Private Healthcare, generous pension scheme and Life Insurance
• Wellness programs and support
• Employee discount scheme
• State of the art offices 
• International career possibilities
• Flexible and Hybrid working
• Help with home office equipment
• Volunteering days
• Support for professional growth in a wide range of learning and development opportunities
• We welcome and embrace diversity providing an inclusive working environment
• The best possible work-life balance is of great importance to us, which is why we support flexible hybrid working model.

#LI-UK 
#Hybrid

Bayer welcomes applications from all individuals, regardless of age, disability, gender identity/expression, family status, pregnancy and maternity, race, religion or belief, sex, and sexual orientation. We are committed to treating all applicants fairly and without discrimination. We continue to progressively embrace and adopt actions to advance our Diversity Equity & Inclusion (DE&I) commitments and aspirations, #ForBetter. 
 
Bayer is committed to providing access and support for all individuals with disabilities and / or long term conditions - during the application process and beyond. At Bayer, sustainability is ingrained in our mission ‘Health for all, hunger for none’, driving our commitment to healthcare and agricultural innovation. We prioritise reducing our environmental footprint, enhancing our social impact, and ensuring sustainable business practices. As part of our team, you'll have opportunities to contribute to various initiatives such as achieving climate neutrality across our facilities by 2030, to improving access to healthcare and nutrition to 100 million underserved people worldwide by 2030. Join us and be part of a culture that values innovation and empowers change, as we strive to shape a healthier, more sustainable, and inclusive world.  
Let us know if there is anything about the recruitment process that you would like to discuss, in particular if there are any changes or adjustments that would make it easier for you to apply please contact nienke.klaar.ext@bayer.com. 

INTERESTED IN THIS POSITION?
Are you looking for a new challenge? Apply online by sending us your resume and cover letter (in 1 document). Do you have a question, or do you want to learn more about the position? You can always contact Nienke Klaar via Nienke.klaar.ext@bayer.com .