At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Driven by our dedication to patients, we bring innovative products, services and solutions to people throughout the world. Janssen is a pharmaceutical company of Johnson & Johnson. Please visit www.janssen.co.uk for more information.
Directs the operational function in medical affairs to achieve interpersonal objectives. Responsible for the design, development and implementation of programs related to educational, promotional and reporting materials for products related to Phase IIIb, Phase IV trials, solicited and non-solicited studies, publications, and so on. At this level, the position has a greater degree of impact on the business results and typically, responsibility for leading a group of professionals.
- Runs the design and implementation plans of medical affairs program, including identification of critical paths, budget development and tracking of all projects.
- Manages and delegates work of direct reports, establishing accountability for assignments.
- Handles creation of educational, promotional and reporting materials for use by internal partners.
- Including publication planning, preparation and review.
- Supports technical training needs of partners and leads review of promotional material.
- Implements plans for clinical trials, including protocol, staffing and budgeting as it relates to business initiatives.
- Ensures that trials/registries are conducted according to all applicable guidelines, regulations, company procedures and high ethical/quality standards.
- Implements policies and procedures for development and provision of medical and technical information pertaining to the company's products for internal use by customer and by government.
- Handles budget, contract negotiation and oversight of vendor activities. Executes the company's drug surveillance/product safety program which includes following up on adverse reaction reports.
- Provides solutions surrounding legal liability and compliance with government.
- Maintains collaborative working relationship between medical affairs and internal partners to deliver timely and authoritative support to product development.
You will ensure all individuals, strategies and processes are in compliance with all relevant guidelines and regulations.
Core Functional Responsibilities:
THERAPY AREA KNOWLEDGE: 25%
- Review summarised literature searches, analysed clinical papers, attend conferences, courses and other such events to be aware of the latest scientific and clinical advances in relevant therapy areas.
- Attend courses and industry meetings, read industry publications and discuss therapy area with colleagues to keep up to date with developments within the pharmaceutical industry and pharmaceutical medicine.
- Monitor competitor promotional and scientific activities so as to understand their ongoing strategies, as well as to assess their compliance with the Code of Practice.
- Synthesize therapy knowledge and data to ensure Janssen therapy area strategy is aligned and course correct where necessary
CUSTOMER/ EXTERNAL EXCELLENCE: 25%
- Meet with identified key customers and researchers on a regular basis through meetings, conferences etc., as required to ensure alignment of strategic directions
- Exchange disease area knowledge and opinions in order to understand the emerging opinions
- Increase the customers understanding of Janssen products and processes (e.g. clinical data, IIS, clinical trials, compliance processes), according to their expressed interests and needs and to seek their advice on the development of our products.
- Manage and maintain positive relationship with Key Opinion Leaders and Deliver scientific and medical content for medical advisory boards.
- To be the point of contact for principal investigators proposing investigator-initiated studies (IIS) and manage such studies in collaboration with GCO
- Support comms dept with patient advocacy groups and their initiatives e.g. responding to clinical interest, gathering insights. Have oversight of these to identify themes
- Lead MAF engagement in the UK Country Value Team, feedback insights from customers in order to contribute to cross-functional (marketing, medical, outcomes research, BI and communications) brand team strategies. Additionally, highlight key aspects of the clinical data so that they form the basis of key marketing messages.
- Engage with internal partners on topics of mutual interest in order to encourage optimal use and/or understanding of Janssen products
- Network with the Global and EMEA Medical Affairs, R&D, GCO, SKM, Medical Education and marketing teams to ensure free flow of information and ideas between the different teams, while aligning objectives.
- Inform the Global and European teams by verbal and written communications of the local country specific differences e.g. applicability of ABPI Code of Practice in the UK, and of the potential impact these differences may have on marketing of a product, feasibility of a clinical trial in a specific country.
- Clinical Trials: Read and amend study proposals to ensure any trials are aligned with Global, Regional and local commercial strategies, within a timely fashion as defined by ReCAP process and ensure relevance to local market.
- Maintain expert knowledge of all relevant local country specific differences, for example applicability of the ABPI Code of Practice in the UK, and the potential impact these differences may have on marketing a product, performing a clinical trial in that country or holding an educational event there.
- Provide support to enable their team to undertake their activities. This may take the form of general or technical advice and will also include facilitating their personal development as well as facilitating progression through the organisation.
- Lead the development of the MAF strategy for allocated therapy area and support the development of compliant materials, aligned to ABPI and HCBI guidelines
- Lead MAF engagement with UK CVT and other internal and external partners to ensure compliance with the necessary Codes of Practice and Laws governing the promotion and sale of medicines within the UK and Ireland.
- Review of materials submitted for copy approval.
- In the event of any potential breaches of the Code of Practice, lead the complaints procedure to defend the position of Janssen including engaging in inter-company dialogue and representation at PMCPA hearing if necessary.
- Medically qualified physician with post registration clinical experience.
- Commercially astute with an eye for business.
- Prior experience working the field of Immunology strongly preferred.
- Deep understanding of the Industry or equivalent experience strongly preferred.
- Dedicated to succeeding in the Medical Affairs environment.
- Highly motivated with the ability to motivate others and succeed in a highly integrated group environment.
- Strong Leadership, mentoring and line management skills
- Strong communication skills - able to build positive relationships
We respectfully request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Janssen-Cilag Ltd, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
Johnson & Johnson are an equal opportunity employer.
United Kingdom-England-High Wycombe-
Janssen Cilag Ltd. (7360)