Senior Director EMEA Medical Affairs and Clinical Research Johnson & Johnson Maidenhead

Job description
Position Summary:
Reporting to the VP, Medical Affairs & Clinical Research, the Senior Director EMEA Medical Affairs and Clinical Research (Med-Clin) will provide medical oversight across the Consumer Group‘s portfolio within EMEA. The portfolio primarily consistes of medicinals, cosmetics, devices and personal care products.

This is a broad role and one where s/he will have responsibility for developing strategies, policies and objectives for a team of 20+ which includes medical affairs, medical information, clinical research and local medical safety functions to achieve company goals and objectives.
This role has responsibility in the short term for prioritization of work and resources. It is essential that the EMEA Med-Clin leader has the capability and leadership skills to develop and orchestrate programs that provide patients/consumers and healthcare providers with meaningful products, helps the company drive growth, continually enhance quality and compliance and strengthen the capabilities and the culture of the organization.
The Senior Director will need to ensure all related medical information, education and promotional information is accurate, relevant and conforms to all applicable regulations.
Work seamlessly with a wide range of cross-functional partners (eg commercial organization, regulatory, safety, quality) to drive innovation, provide support for marketed products and manage of issues.
As a member of the Global Med-Clin leadership team provides medical and organizational leadership with EMEA and globally.
Work cross functionally to prepare for RX to OTC switch programs.

Role Responsibilities

Brand Teams
Line management of the EAME Medical Affairs Category Managers (EMAMs).
Oversee the provision of clinical / medical support for Oral Health, Smoking Cessation, URTI/allergy, Eye Care and Intimate Care brands
Provide direct support to Moderate Growth and Maintenance brands
Support EMAMs in building strong partnerships with all business colleagues, particularly the Regional Brand Managers, in order to implement brand strategies
Oversee the EMEA team’s input to the clinical/medical sections of R&D Category Reports on a monthly basis
Contribute to R&D strategy documents and implementation


Management
Lead and manage the EMEA medical affairs organisation
Create a strong development culture, ensuring personal development plans are in place and their delivery facilitated, and that succession planning is undertaken
Coach and where necessary provide direct guidance to/share expertise with other team members to ensure that their contributions are maximised
Ensure appropriate resources available to deliver the business objectives
Assist in the maintenance and development of appropriate systems and processes within EAME to ensure quality, efficiency and the measurement of performance
Recruitment and retention of talented, capable and committed staff


Clinical Development
Lead Medical Affairs in the provision of medical insights to stimulate product innovation
Coordinate and where appropriate contribute to, the development of clinical development plans
Ensure commercial requirements are fully considered through close liaison with business partners
Shape research proposals and protocol development
Support the successful completion of studies according to GCP
Coordinate the writing of study reports and publications
Oversee the review and approval of investigator grant studies
Contribute to development of POM to P switch strategy

Regulatory
Work closely with Regulatory Affairs colleagues to ensure the data provided to regulatory agencies is accurate, and that our products are properly represented
Oversee the preparation of medical documentation for registration dossiers:
Medical dossiers
Clinical Expert Reports
Expert Statements
PIPs – safety & claim support
Contribute to the development and sign off of product labelling as appropriate:
SmPC
PIL
Pack labelling
Meet with regulators when requested to understand their needs and provide medical expertise in support of our products
Assess / predict changes in medical requirements and recognise the potential international impact
With local markets, monitor literature sources relevant to our Brand categories


Pharmacovigilance
Oversee the preparation of expert statements for PSURs submitted in EAME
Provide support to the European QP for Pharmacovigilance function in order to ensure compliance with European Pharmacovigilance legislations and Volume 9 (Pharmacovigilance, of the Rules governing medicinal products in the European Union).
Publish Pharmacovigilance compliance data prepared by Compliance Science in Regional Reg/Med Monthly report
Provide Medical advice to the European QP as required.


Medical Information
Support the affiliates by providing standard letters and Q&A materials for key issues
Facilitate the sharing of medical information throughout the Regional affiliates


KOL Development
Oversee the development of professional endorsement programmes by the EMEA team in conjunction with professional marketing. Input into global programmes where appropriate.
Support team in gaining opinion leader endorsement to support products and/or claims
Oversee coordination of symposia
Publication planning
Establish and support professional programmes at a European level & help roll out at local level


Medical Marketing

Input into European/Global claim/advertising development process
Oversee assessment of proposed Claims/Advertising for medical/clinical accuracy and balance in line with EU law
Manage development and maintenance of Medical/Clinical supports for claims/advertising
Oversee Regional Promotional/Advertising Copy Approval Process
Liaison with affiliates on execution of claims and promotional material within currently registered SmPC
Identifies potential threats to claims and inputs into strategies to maintain/ defend claims in conjunction with local and global medical
Provides scientific evidence to affiliates for defence of claims against competitive threat
Liaise with local Regulatory/Medical and EMEA Brand Director to monitor competitor activities (new products, claims, pipeline developments, providing opinion) and assisting affiliates compile competitive challenges


Market Research
Advise and approve concepts for testing in Europe
Liaise with Regional and Affiliate regulatory managers on utility/applicability of proposed copy/claims
Help local medical team in the design and coordination of market research studies where requested


Training
Oversee the development of training courses & materials on clinical / medical / scientific aspects of new products or claims
In house staff
external professionals
Provide support documentation for R&D & marketing affiliates
Training new starters in Medical Affairs and new category members on therapeutic area when appropriate

Job Function

Medical Affairs

Skills

This is a challenging role and one that requires an equal balance of technical skills and experience with leadership capabilities. Therefore the ideal candidate should possess:
Medical Degree,
Have worked in a blue chip organization(s) and have had excellent medical affairs/clinical research training with experience in key therapeutic areas
Can demonstrate the leadership of a team, and where development and mentoring has taken place.
Have contributed to or defined a medical affairs/clinical research strategy
Operated at a sufficiently senior level so that he/she is called on at the most senior level for advice/guidance and be able to operate independently with confidence
Able to thrive in a changing or high degree of ambiguity where the road map for results may not be determined or is evolving
Have experience of change management and understand the impact on others
Able to multi task- and effectively operate under a somewhat pressurized environment and coach and guide others how to work accordingly
Have a broad understand of GCP and regulatory requirements, have a passion for quality & compliance and process excellence.
Be an exceptional communicator, able to represent the organization with authority and competence with a broad range of external stakeholders including health authorities, professional and consumer organizations
Able to challenge the status quo when needed


Essential
Medical degree
Broad experience in the pharmaceutical industry including medical affairs and clinical research, supporting relevant therapeutic areas
Excellent communication skills, including spoken and written English


Desirable
A specialist post-graduate medical qualification
Diploma in pharmaceutical medicine or equivalent
Good understanding of Pharmacovigilance practices and legislations
Certificate of Completion of Training, Pharmaceutical Medicine

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