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About the job
The Internal Medicine Business unit at Pfizer is looking for a final signatory with experience of peri-launch activities who can act not only as a signatory but as a business partner with the commercial and medical teams. This role will be part of the Internal Medicine Code Approval Team at Pfizer where group members are responsible for a variety of different therapy areas, medicines and approval of appropriate pre-licence activities in a number of pipeline areas of strategic interest to Pfizer. At Pfizer we work with different types of content, with a strong focus on digital materials. The successful candidate needs to be a team player who can work in a fast-moving, agile team with marketing and medical colleagues to successfully develop and deliver code complaint materials that have meaningful impact.
The person will:
Support Pfizer’s transformational change in how we engage with patients and physicians using high quality, engaging multi-channel content.
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 (eg patient experience/engagement roles, healthcare development), as well as colleagues outside the BU working on BU related activities, such as corporate affairs colleagues.
Provide end-to-end medical partnership to the nominated internal team(s), from strategic conception of a programme to content development and approval.
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.
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 Professional (AQP)
Provision of Medical Expertise in Relation to Content of Materials:
- To work with the product medical affairs team to acquire and maintain in-depth scientific knowledge of the Pfizer medicines and understand the clinical landscape within the therapy area (including medicines in development where applicable)
- 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
- 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 eg pre-vetting submissions to the MHRA
- advising on and reviewing materials for package deals and materials for patient support programmes (eg Homecare)
- To work in collaboration with cross-functional team(s) on preparation, review and approval 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.
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 toshape 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, Experience And 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 comprehension of the UK healthcare system
- For pharmacy applicants UK registration is required
- Significant pharmaceutical industry experience in medical affairs as a Code signatory, including peri-launch activities
- In-depth knowledge of Code review and certification requirements gained through relevant industry experience
- Collaboration evidenced by effective team working
- Excellent comprehension of the NHS environment
- Strong comprehension of the business and of commercial and medical roles
- In depth knowledge of the typical commercial and medical activities in the UK pharmaceutical industry (eg promotion, medical education, external partnerships, advisory boards)
- Deep product and therapy area knowledge will be 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
- Comprehension 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
- 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 comprehension 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.
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.
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 is committed to celebrating this, in all its forms – 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.
Vacancy Type: Full-time · Mid-Senior level
Job Location: United Kingdom
Application Deadline: N/A
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