Medical Affairs Manager: Code Signatory

Medical Affairs Manager: Code Signatory & Business Partner page is loaded Medical Affairs Manager: Code Signatory & Business Partner Apply locations United Kingdom - Remote time type Full time posted on Posted 2 Days Ago job requisition id 4910429

Medical Affairs Manager: Code Signatory & Business Partner

ROLE SUMMARY

Purpose

Here at Pfizer, we are passionate about science and innovations. We are patient centric company, guided by our four values: courage, joy, equity and excellence. If you share this passion this role is an excellent opportunity to become part of the dedicated Code Approval Team playing key role in supporting Pfizer’s transformational change in how we engage with patients and physicians using high quality, engaging multi-channel content.

To provide specialist Code advice and review, examination and certification services to the nominated internal team(s) to support the appropriate use of Pfizer medicines and successful implementation of Pfizer’s promotional and non-promotional materials, initiatives and programmes. These internal teams may comprise sales and marketing colleagues and those in non-promotional roles (e.g., patient experience/engagement roles, healthcare development), as well as colleagues outside the BU working on BU related activities, such as corporate affairs colleagues.

To provide end-to-end medical partnership to the nominated internal team(s), from strategic conception of a programme to content development and approval.

To maintain the highest standards for Pfizer material in line with the ABPI Code of Practice, other applicable laws and regulations and Pfizer policies, ensuring that content that is approved for use with UK health professionals, other relevant decision makers, patient groups, patients, the public and the media is appropriate, relevant and reflects Pfizer’s position as a leading ethical, scientific company. 

ROLE RESPONSIBILITIES

Provision of Code Expertise as Final Medical Signatory:

• To review and certify promotional and non-promotional materials and activities in line with the requirements of the ABPI Code of Practice. 
• To review and sign-off materials as the Appropriately Qualified Person (AQP)

Provision of Medical Expertise in Relation to Content of Materials:

• To acquire and maintain in-depth scientific knowledge of Pfizer medicines within nominated therapy area(s) (including those in development) as well as the competitive landscape. 
• To understand and advocate the appropriate use of medicines with the UK health system

Collaboration with Pfizer teams to Enable Streamlined Content Creation:

• To work with the nominated cross functional team(s) in-country and above-country to develop impactful and compliant promotional and non-promotional materials of value to healthcare professionals and patients. This includes for example:
  • advising on marketing programmes, other promotional activities and medical education
  • providing support for revisions to prescribing information and implementation of risk management plans
  • working with digital materials and digital technologies
  • collaborating with Medical Affairs colleagues to understand therapy area and share pertinent issues with the relevant teams
• To provide specialist medical, scientific and Code advice to teams during the development phase of materials/projects/activities to support streamlined creation of compliant content/activities that enable appropriate use of Pfizer medicines and successful implementation of materials, initiatives and programmes for example:
  • advising on and reviewing materials for submission to health authorities e.g., prevetting submissions to the MHRA
  • advising on and reviewing materials for package deals and materials for patient support (e.g., Homecare)
• To work in collaboration with cross-functional team(s) on preparation and review of training materials for colleagues
• To provide advice that will ensure that the highest ethical standards are upheld and that Pfizer always remains compliant with regulations.
• To provide clear feedback and suitable recommendations to enable the above.

Provision of support for above-country activities that fall within scope of the UK Code of Practice

• To collaborate and review, where required, global materials and activities, for example advisory boards, symposia, PAG donations, market research. 
• To ensure relevant UK Medical Affairs teams are kept abreast of global initiatives in market

Thought Leader for Promotional Compliance Strategy

• To work in collaboration with the Code Approval Team and compliance leads to shape and evolve the promotional compliance strategy for Pfizer UK and to enable industry leading ways of working that are high quality, ethical and streamlined.

Support for Regulatory Labelling and Licence Maintenance Activities

• To support cross-functional teams in the management of label updates (SPC, PIL, PI)
• To support cross-functional teams in licence maintenance activities, including variations and renewals

Inclusive and time efficient working:

• To work collaboratively with team members and to agreed timelines. 
• To effectively manage own time and workload.

Management of Complaints:

• When required, to work collaboratively on managing complaints or intercompany dialogue with internal and external stakeholders. Advise on corrective and preventative actions.

SKILLS, QUALIFICATIONS AND EXPERIENCE

Education:  

• Registered physician or UK registered pharmacist.
• For medical applicants GMC registration with a Licence to Practice is preferred. Doctors registered outside the UK may be considered if they are capable of being registered in the UK without the need for additional tests of medical/clinical knowledge (i.e. PLAB exempt) and if they have significant pharmaceutical industry experience and understanding of the UK healthcare system
• For pharmacy applicants UK registration is required

Experience:  

• Significant pharmaceutical industry experience in medical affairs as a Code signatory
• In-depth knowledge of Code review and certification requirements gained through relevant industry experience
• Collaboration evidenced by effective team working
• Excellent understanding of the NHS environment
• Strong understanding of the business and of commercial and medical roles

Technical:  

• In depth knowledge of the typical commercial and medical activities in the UK pharmaceutical industry (e.g., promotion, medical education, external partnerships, advisory boards)
• Deep product and therapy area knowledge acquired through training on the medicines being supported
• In depth knowledge of the ABPI Code of Practice and MHRA Advertising Regulations
• Successful completion of the Pfizer Signatory Exam
• Understanding of the regulations associated with medicines research, such as clinical trials and real-world data and the strengths and limitations of different types of data 
• In depth knowledge of Pfizer policies in relation to Code review and certification of promotional and non-promotional materials acquired through training.
• Understanding and ability to interpret and advise on statistical concepts to ensure fair and balanced representation of data in an easily understandable format
• Competency in searching and interpreting medical literature 
• Experience in reviewing digital assets e.g., websites, apps etc.
• Fully conversant with all relevant Pfizer policies and procedures acquired through training.
• A proactive approach to championing compliance to enhance industry reputation.
• Upholds values and drives high standards.
• Fluency in Business English 

Core digital capabilities

• Capability to use digital technology provided by the organisation
• Confident and competent with digital compliance requirements
• Experience in using a range of digital platforms
• Basic understanding of core digital metrics used by the organisation
• Awareness and integration of digital channels to meet our customer needs
• Understanding and ability to apply ABPI and international Code of Practice regulations to digital projects

N.B digital technology refers to equipment/applications and digital platform refers to the software/hardware used to host applications/ exchange of information.

Closing Statement

The closing deadline for applications is April 28th.

All applicants must have the relevant authorisation to live and work in the UK.

Work Location Assignment: Remote

Purpose

Breakthroughs that change patients' lives ... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility 

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here