Responsible for the Digestive Health franchise, and portfolio of products in Globally. Responsibilities for Medicines and Medical Devices. Responsibilities for Herbal Medicines and Medical Devices cross-franchise. Development and implementation of commercial objectives and strategies for DH products. Harness scientific data related to both new and existing products, and related promotional claims, and to ensure their appropriate use in accordance with the category strategy. Cross-functional collaboration with Marketing, Regulatory, R&D, and Consumer Insights franchise teams as well as local country affiliates to ensure consistency and alignment in the provision of scientific support. Provision of expertise on safety and effectiveness of products. Provision of scientific and clinical information to franchise teams to support product registration and marketing of approved products. Due diligence assessment of suitability of potential product acquisitions. Developing campaigns with larger teams which are scientifically supportable and commercially focused. Development and approval of key communication messages and materials for professionals and consumers. Translate strategy into actuality. Provision of informed medical and scientific opinion to RA and Marketing colleagues. Clinical protocol development and interpretation of study results. Clinical Overview and Clinical Evaluation Reports authoring, rationales and justifications for transmission to Regulatory authorities or Notified bodies in for introduction of new products, or maintenance of licenses. Medical strategy for new and existing product development. Medical leadership in line with business strategies. Scientific/process training to Company functions and Medical Affairs contractors. Management of 4 MA colleagues (third party contractors) based remotely (Philippines). Coaching junior team members to ensure that their contributions are maximised. Provide medical insights to stimulate product innovation.

Medical Affairs professional responsible for the Cough/Cold (Globally) and Allergy franchises and portfolio of products (Medicines and Medical Devices) in the Europe, Middle East and Africa.Responsible for contributing to the development and implementation of commercial objectives and strategies for product(s) in the consumer healthcare arena.Key responsibilities include:Provision of expertise on safety and effectiveness of relevant products. Developing campaigns with larger teams which are scientifically supportable and commercially focused.Development and approval of key communication messages and materials for professionals and consumers.Harnessing scientific data related to existing & new products and related promotional claims and ensuring their appropriate use in accordance with the category strategy.Working with opinion leaders to help in the development of strategies, lobbying opportunities, new product development, claims and in the communication and acceptance of key data and messages.Reviewing and advising on suitability of new products from a clinical, claims, and safety perspective.Ensuring the provision of informed medical and scientific opinion to EMEA Regulatory Affairs and Marketing colleagues.Preparing expert summaries and rationales for onward transmission to European regulatory authorities in support of the introduction of new consumer products, or in the maintenance of licenses of established products. To be the credible internal subject matter expert and provide appropriate in-house scientific training. Provision of scientific advice and information in response to enquiries from affiliate R&D departments and ensuring that the standard response documents used by local market medical information are accurate and up to date. Direct line management of 2 Medical Affairs colleagues based remotely (Spain and Italy), with a team of 4.

Medical Affairs Consultant for the EMEA Region at Johnson & Johnson Consumer Services.Medical Affairs professional responsible for the Cough/Cold and Compromised Skin franchises and portfolio of products (Medicines and Medical Devices) in the Europe, Middle East and Africa. Responsible for contributing to the development and implementation of commercial objectives and strategies for product(s) in the consumer healthcare arena.Key reponsibilities include:Provision of expertise on safety and effectiveness of relevant products. Developing campaigns with larger teams which are scientifically supportable and commercially focused.Development and approval of key communication messages and materials for professionals and consumers.Harnessing scientific data related to existing & new products and related promotional claims and ensuring their appropriate use in accordance with the category strategy.Working with opinion leaders to help in the development of strategies, lobbying opportunities, new product development, claims and in the communication and acceptance of key data and messages.Reviewing and advising on suitability of new products from a clinical, claims, and safety perspective.Ensuring the provision of informed medical and scientific opinion to EMEA Regulatory Affairs and Marketing colleagues.Preparing expert summaries and rationales for onward transmission to European regulatory authorities in support of the introduction of new consumer products, or in the maintenance of licenses of established products.To be the credible internal subject matter expert and provide appropriate in-house scientific training. Provision of scientific advice and information in response to enquiries from affiliate R&D departments and ensuring that the standard response documents used by local market medical information are accurate and up to date.

Part of the Medical/Regulatory team working on the Product Information Update project, determining all products within the Company (Worldwide Marketing Authorisations) that require updates to their safety information, performing these updates and completing relevant submissions to the local regulatory authorities. 53 molecules, approximately 1,118 MAs (543 Europe, 575 ROW) across 89 (27 EEC and 62 ROW) territories.Medically and Scientifically assessing the relevant product information, utilising Company Core Safety Datasheets, Medical and Scientific references and literature searches to produce up-to-date scientific documents for the products marketed by the Company, including SmPCs, PILs and Clinical Expert Statements in compliance with: - PSURs received from Pharmacovigilance (PV) and PV partners;- Requests for Further Information from Regulatory Agencies; - Harmonisation of SmPC/PIL for different countries as per the regulatory requirements/variation.Strong understanding of SmPC verbiage and patient-friendly language necessary for PILs. Methodically analysing the data, making comparisons and presenting these to the team for agreement. Cross-functional working - Collaborating across the unit to achieve operational effectiveness.Medical writing – Preparation of responses to Regulatory Authorities, in the UK and Worldwide, Requests for Further Information (RFIs), writing of Clinical Expert Statements (CES) to support Product Information Updates. Review of internally and externally prepared Clinical Expert Statements for Medical/Scientific content. Product Profile creation; CCDS creation; Product Risk assessments, Responses to European Product referrals.Training and management of new starters to the project. Training on processes and guidance in Scientific/Medical content of SmPCs/CESs. Management reponsibilities in Managers absence.

Providing Scientific and Medical support for products within the Company’s portfolio. Providing clinically focused Medical and Scientific responses for a variety of projects within the Business required as part of holding a Marketing Authorisation (Variation submissions, maintenance and updates to Product Information, new Marketing Authorisation applications, and higher level Medical Information enquiries). Medical writing – Preparation of responses to Regulatory Authorities, in the UK and Worldwide, Requests for Further Information (RFIs), Clinical Expert Statements (CES) to support/justify Product Information Updates, Risk-Benefit reviews, Article 31 referral responses and internal scientific reports. Maintenance of updates to Company Product Information; providing analysis and reviews of SmPCs, PILs, and Company Core Data Sheets.Organisation, Management and Overview of the Medical Departments Signal Detection activities to ensure continued monitoring of the safety of the Company products.Critical review of weekly literature searches for Company products to identify any new clinical information, adverse reactions or safety issues.Reviewing and approval of Company Artwork components. Participation in the review of Company product promotional material in line with ABPI Code of PracticeActive member of department Training Team; creation and delivery of training materials to the department and company, relating to scientific/clinical knowledge and systems/processes.Involvement in Medical Department and Company-wide projects: Scientific information/reports to assist other departments within in the Company in responses to Regulatory Authorities, Product Profile creation; Product Risk assessments, Responses to European Product referrals.Clinical trial sponsor management: Management of Medical department’s involvement in a new MA application.

Part of a team providing an effective and proficient drug safety service to support the medical and commercial activities of Amdipharm plc and Sovereign MedicalProviding timely, accurate and relevant medical and scientific to internal and external customers; ensuring that information is technically accurate and consistent with prescribing informationResponse to enquiries originating from healthcare professionals and members of the public worldwide, as well as internal staffCritical review of weekly literature searches for Company products to identify any new clinical information, adverse reactions or safety issuesEstablishment of library of relevant Clinical papers for Company productsClose relationships with Pharmacovigilance team, Technical Department and Commercial department in coordinating exchange of adverse event reports, product quality complaints and stock level informationManagement and administration of the Company Medical Information database. Included user requirement testing, maintenance of database and standard responses, training of new usersMaintaining Company product information – review and updating of product information on eMC and IPHAPreparation of PSURs.

Teaching Biology, Chemistry and Physics in a state Secondary schoolResearching, planning and executing lessons across age range 11-16Ensuring Health and Safety of students at all timesUndertaking training and research in effective teaching techniques to ensure lessons taught are of the highest standardCooperating with and adhering to school policy and cultureFollowing National Curriculum guidelines.

Gene and protein analysis of Mycobacterium tuberculosis P450 systems. Research employed molecular biology, cloning and protein purification procedures. Results were required to be documented through extensive written reports including background research and critical analysis. My research also needed to be relayed to fellow laboratory members, undergraduate students and at international conferences so involved many oral presentations to a variety of audiences and numbers, with information elaborated or condensed depending on the audience levelAssisting Undergraduate Biochemistry students in practical lessons, explaining theories and demonstrating techniques to a wide variety of undergraduate students.Present lecture on my research at an International conference – Dallas, Texas 2006. Audience consisted of the majority of leaders in the fieldSeveral research articles published in high impact journals including the following: o The preponderance of P450s in the Mycobacterium tuberculosis genomeMcLean K.J., Clift D., Lewis D.G., Sabri M., Balding P.R., Sutcliffe M.J., Leys D., Munro A.W. Trends in Microbiology 2006 14:5 (220-228) o Analysis of the cytochrome P450 complement in the human pathogen Mycobacterium tuberculosis, Clift et al. Proceedings of the 14th International Conference on Cytochromes P450: Biochemistry, Biophysics and Bioinformatics (2005) p134o Biodiversity of cytochrome P450 redox systemsMcLean K.J., Sabri M., Marshall K.R., Lawson R.J., Lewis D.G., Clift D., Balding P.R., Dunford A.J., Warman A.J., McVey J.P., Quinn A.-M., Sutcliffe M.J., Scrutton N.S., Munro A.W. Biochemical Society Transactions 2005 33:4 (796-801)