Performance driven, entrepreneurial, healthcare professional with a proven track record of helping pharmaceutical, healthcare and other industry clients develop new services to achieve high performance in medical and scientific affairs, including regulatory reviews, audits, medical education and scientific communications.
Main areas of expertise include the interpretation and dissemination of complex clinical data and scientific information in user-friendly language and the provision of international strategic, logistical and hands-on medical/scientific/regulatory & safety support for pharmaceuticals, medical devices and also cosmetics and consumer products.
President, London Region @ Brand Institute (BI) and it’s subsidiary Drug Safety Institute (DSI) are a global brand identity consultancy specialising in the development of proprietary (brand/line extension) and nonproprietary (USAN/INN) names for the global healthcare/pharmaceutical marketplace including expert support services for both pre- and post-marketing activities, including: trademark/legal, marketing research, safety research, design services and also regulatory services such as name safety testing, rebuttals and submissions assistance.
• Led the London regional business covering: UK, Nordics (Ireland, Sweden, Norway, Finland) and emerging markets including India.
• Identified and developed new business leads.
• Drove strategy for new business including proposals and pitches, and presented at pitches when required.
• Liaised internally with global ops teams to ensure efficient project management of products & services and delivery across multiple projects.
• Trained, mentored, and oversaw the development of local directors and team members ensuring best practice across teams. From July 2011 to October 2011 (4 months) Head of Scientific Affairs @ GlaxoSmithKline's Dermatology Business.
• Re-engineered different divisions including global information services, medical information, training & education and scientific communications into a new and effective functional group namely scientific affairs. Also overhauled and created a standardised international medical information service.
• Interpreted and repackaged complex scientific information in user-friendly language for substantiation of claims and development of regulatory and marketing materials.
• Reviewed promotional, regulatory, educational and other materials for global and local country markets enabling the strongest claims consistent with regulatory authority requirements.
• Managed training from approval of materials to the delivery of training.
• Handled medical and scientific communications from conferences to managing content of internal and external websites.
• Managed regulatory audits and high level complaints from customers, competitors and regulatory bodies including regulatory appeals - delivering optimal outcomes, saving the company from large fines and safeguarding its reputation by averting risk from prosecution and adverse publicity.
• Provided medical and scientific direction to marketing teams into pipeline asset development, brand positioning, pricing & reimbursement and clinical trial strategies. Also provided research and assessments of new revenue sources to sustain on-going business growth including compounds, technologies, and products.
• Key member of the European R&D leadership team identifying critical success factors, developing strategies, operational models and plans for logistical implementation of decisions.
• Played a vital role in managing company’s successful integration with GSK, proposing solutions and resolving issues to ensure balance of cost-saving synergies and maintenance of value functions. From November 2008 to June 2011 (2 years 8 months) Medical Information Consultant @ Headhunted by a new start-up company called Access 24, founders of a novel healthcare and medical information service for medical insurance and pharmaceutical companies. Company was acquired by AXA Assistance in 2001.
• Recruited into a specifically created role to develop medical information services and also provide medical information enquiry handling service, as needed.
• Negotiated a new (still ongoing) contract, following company’s acquisition by AXA, as an external out-of-hours employee, providing backup medical information service and support. From August 1999 to December 2010 (11 years 5 months) Clinical Pharmacist, Locum @ Clinical Pharmacy Practice - Primary and Secondary Care in both NHS and Private Sectors
• Played a key role in the set up of the first Ambulatory Care and Diagnostic Centre in the UK. Developed plans and process maps to deliver unique pharmacy services befitting a novel scenario.
• More than 20 years of direct patient care and clinical practice experience serving various demographic populations throughout the UK including numerous NHS teaching hospitals, private hospitals, community pharmacies and also a prison pharmacy.
• Managed a wide-range of therapeutic areas covering most hospital speciality wards. Also various divisions within the pharmacy department itself, including medical information, aseptic manufacturing, dispensary etc.
• Developed educational literature and clinical training materials on many therapeutic areas and trained doctors, pharmacists other healthcare professionals. Also tutored pre-registration pharmacists.
• Still committed to staying in-touch through occasional locum roles as time permits. From 1986 to 2009 (23 years) United KingdomMedical Affairs Consultant @ Employed twice:
• First to develop a robust international Medical Information and Pharmacovigilance (MIP) service and resolve existing service issues.
• Invited back to handle an MI part of MHRA inspection (passed successfully with no findings) and also to set-up a new global MIP database called IRMS. From 2007 to 2008 (1 year) Pharmacovigilance, Drug Safety Consultant @ Enlisted twice:
• First for the set-up and implemention of a new global safety database called PV works™ for over 275 products treating a wide range of therapeutic-indications.
• Later to assist with the resolution of a backlog of adverse event case reports and periodic safety update reports (PSURs). From 2007 to 2008 (1 year) Founder and Managing Director @ Founded a successful limited company focused on bringing a novel product to UK market.
• Negotiated a sole UK distributor contract with manufacturer, developed a detailed business strategy, a company website and also set up both wholesale and retail sales channels.
• Recruited and developed a premiere team of five office based staff to run the entire business and persuaded Ernst & Young to provide complimentary mentoring for the group.
• Enlisted a team of eight national field-based sales personnel and developed an online sales portal to maximise revenue.
• Personally acquired a number of accounts including BNP Paribas and London Aquarium, and also initiated discussions with the NHS.
• Sold the company in 2008 after ensuring the business was established and profitable. From 2006 to 2008 (2 years) London, United KingdomAccounts Director - Consultant @ Headhunted by a start-up property search agency, sourcing and matching property acquisitions between developers and clients, with focus on first time buyer and investor markets.
• Recruited to participate in the set-up of the company - developed business strategies, managed resources, negotiated new business partner licensing agreements and managed client relationships.
• Headed the management of all client accounts and client communications and ensured cultivation of excellent working relationships with clients, customers and industry regulators.
• Managed teams across two business units, devised operational, marketing and sales strategies.
• Developed software to support and enhance capabilities including development of a Web catalogue and procurement portal on company website, as well as tracking systems and databases to follow market trends, generate leads and identify operational gaps and issues.
• Revamped sales literature, trade advertisements and PR campaigns to ensure compelling value propositions and provide new business opportunities. Also generated revenue through direct sales leading to an overall, 30 percent, increase in revenue over a period of 6 months. From June 2006 to December 2006 (7 months) London, United KingdomAcademic Research Scientist @ • Awarded a PhD scholarship to develop a novel liposomal drug delivery agent for efficient and target-specific delivery of drugs in the body - such as the delivery of cytotoxic agents to tumour sites.
• Gained 7 years of invaluable scientific and clinical research experience in pharmaceuticals.
•Developed a keen eye for detail, accuracy, lateral thinking and astuteness in problem solving as well as experience of using a variety of analytical techniques.
• Also acquired insight onto their capabilities for broader applications in other areas of research and development of products and technologies.
• Was invited, as a visiting lecturer, to give a series of lectures in pharmacology to BSc students at the University of Westminster. Involved development, delivery and assessment of coursework and exam questions for the entire module and provided valuable experience in teaching and lecturing. From October 1999 to February 2006 (6 years 5 months) London, United Kingdom
Pharmacy @ King's College London, U. of LondonUniversity College London, School of PharmacyUniversity College London, School of Pharmacy Nargis Ara is skilled in: Project Management, Leadership, CRM, Pharmaceutical Industry, Management, Clinical Trials, Pharmacovigilance, Contract Negotiation, Auditing, Training, Strategy, Medical Devices, Healthcare, Business Development, Clinical Research, Medical Affairs, Oncology, Radiopharmacy