Job Description – Medical Affairs Executive v3 pg. 1 Job Description General Information Position Medical Affairs Executive Reports to Senior Medical Affairs Executive/Medical Affairs Manager Department Northern Europe Medical Affairs, Johnson & Johnson Ltd. Location Maidenhead Office Direct Reports 0 Indirect Reports 0 Global Band Full/Part Time Position Summary Provide medical support to the Northern Europe Area, to include: contributing to new product development (NPD) and launches, approval of promotional activities in accordance with relevant legislation and to assist in the provision of accurate clinical and technical information service for Johnson & Johnson Ltd. products. Major Duties & Responsibilities Provide medical review and approval of promotional materials and activities in accordance with applicable Codes of Practice and regulations, Company policy and any other relevant regulations Assist in development of new claims for key brands Partner and collaborate with internal departments as appropriate e.g. Hub Marketing, Regulatory Affairs (UK/Ireland/Nordics), Customer Development, Shopper Marketing, Customer Services, and Commercial Activation Managers (Ireland/Nordics) Assist in the defence of key claims upon challenge by competitor companies and challenge on competitor advertising as appropriate Assist in writing and amending SmPCs (Summary of Product Characteristics), PILs (Patient Information Leaflets) and label information Job Description – Medical Affairs Executive v3 pg. 2 Participate in the production of written documents, including clinical overviews and umbrella branding statements to be submitted to regulatory agencies as required, with support from Senior Medical Affairs Executives Liaise with 3rd party outsourcing agents to ensure that enquiries are handled efficiently, accurately and in a timely manner Provide a Medical Affairs service to in-house personnel (e.g. Regulatory, Marketing and Sales), seeking advice from more Senior members of the Medical team where necessary Where required, assist senior members of the team in the development and evolution of processes and procedures e.g. SOPs / Working Practices Ensure external stakeholders (e.g. PAGB) are informed of new product launches or discontinuations in a timely manner Populate and maintain in-house Medical Affairs systems (e.g. Core claims database) Key Working Relationships Outside Johnson & Johnson Ltd: Trade associations including ABPI and PAGB Healthcare professionals including pharmacists, smoking cessation advisors and doctors Associations of healthcare professionals, including pharmacists and doctors Regulatory Agencies Non-governmental organisations Within Johnson & Johnson Ltd: Medical Affairs (local, regional and global) Marketing, especially Professional Marketing (local, regional and global) Field sales force Regulatory Affairs (local and regional) Customer Development (local) Global Clinical R&D Helsingborg Quality Job Description – Medical Affairs Executive v3 pg. 3 Legal Reporting staff None Main performance measures Accurate review/approval of promotional materials and activities Development of new claims Defence of key claims upon challenge by competitor companies Accurate wording on SmPCs/PILs/label information (where applicable) Accurate production of ‘regulatory’ documents such as clinical overviews and umbrella branding statements Efficient and accurate handling of medical information enquiries SOPs and WIs kept up to date Timely notification to external stakeholders of new product launches or discontinuations Maintenance of core claims database(s) Agreed and signed by: Employee Name Employee Signature (including date) Supervisor’s Name Supervisor’s Title Supervisor’s Signature (including date) Job Description – Medical Affairs Executive v3 pg. 4 Job Requirements Education Degree in Pharmacy or a Life Science (preferred 2:1 or above) Experience Experience in the Pharmaceutical/OTC Industry within a medical role (must have copy review experience if a medical information background) Working knowledge of relevant advertising codes of practice (PAGB/ABPI) desirable Experience within consumer healthcare / OTC an advantage Technological competencies Good working knowledge of Microsoft Office including Word, Excel, PowerPoint and Outlook Key competencies Ability to build and establish strong and productive relationships Demonstrates exceptional attention to detail Strong and effective communicator (both internally and externally) Excellent standard of written English Ability to prioritise work effectively Demonstrates ability to work with teams and individuals Easily adaptable and receptive to change Job Description – Medical Affairs Executive v3 pg. 5 This description is not exhaustive and does not devote or limit the scope of your role. In addition, you will be required to undertake any other reasonable duties or changes of responsibility in accordance with business requirements.
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