Medical Affairs Manager, UK & Ireland - 12 month Fixed Term Contract-00000TBI
Description
Job Title: Medical Affairs Manager UK & Ireland
Reports To: Professional Affairs Director UK & Ireland
Franchise/Department: J&J Vision Care, Professional Affairs
Location: Pinewood, Wokingham
Background Information
This member of the professional affairs team will strengthen the scientific, clinical and technical support to the local PAF team, the organisation and its customers, in addition to shaping the external environment to meet future business needs.
Job Purpose
The Medical Affairs Manager’s primary role is to ensure robust scientific review and claims substantiation of all customer facing materials, ensure full regulatory and health care compliance through liaison with regulatory, educational and compliance bodies, and provide technical support to customers, sales and customer services. In addition this role will develop and execute plans to shape local external environment to support future business needs. They will be the key liaison between Universities and will also be called upon to write publications, clinical conference materials and other clinical flashcards. This will be achieved by means of the roles and responsibilities set out in sections 3 and 4.
Key Dimensions
- To keep up to date with the latest research and advancements within vision care correction.
- To understand the interaction between Professional Affairs, TVCI and marketing.
- To understand the professional, technical and clinical support needed by key accounts, key independent customers, our sales force and customer services.
- To understand technical, clinical and performance attributes of JJVC products, key study results and claims, and differences with key competitor products.
- To be aware of the regulatory framework under which JJVC products are sold.
- To understanding the legal and Health Care Compliance policies.
- To understand the clinical trials process for company sponsored and investigator initiated trials and the generation of new information and claims
Main Job Role
- Scientific review and copy clearance ensuring claims substantiation, regulatory compliance of all professional and marketing materials.
- Develop and maintain strong links to regulatory authorities, competent bodies and professional bodies to help shape future environment.
- Lead medical vigilance investigation and reporting
- Crisis / issue management.
- Raise scientific profile and optimise awareness of JJVC and products through written and verbal communications
- Aid optimisation of customers’ and key influencers’ awareness of the technical and clinical benefits of JJVC products, and compared to competitors’ products
- Presentations at local conferences and customer-facing meetings and responding to unsolicited questions as required
- Publication plan execution with effective leveraging of articles generated by EMA Medical Affairs or published in other local markets.
- Generate new clinical articles (with KOL/PAC)
- Expert on clincial and technical product/category related questions for internal teams (marketing, customer services and sales organisation) and ECPs
- Provide guidance to the organisation on learnings from external scientific publications and clinical conferences
- Sales team training and new recruits technical training
- Foster excellent relationships with key opinion leaders and develop programme to ensure support of JJVC
- University liaison
- Execute pre- and post- launch performance surveys of new and existing products (fit panels) with support from EMA MRD/CSI and Medical Affairs
- Assist EMA Medical Affairs with local company sponsored clinical trials for generation of new information and claims and aid in site selection and field support for studies
Qualifications
Knowledge / Experience / Skills required
Essential:
- Qualified eye care practitioner (optometrist, contact lens optician or ophthalmologist)
- Minimum 5 years experience in contact lens practice
- High level of interest and technical knowledge of contact lenses
- Demonstrable experience of working successfully in a team
- Good presentation skills
- High verbal and written communication skills
- Computer skills including Powerpoint, Word and Excel
- Understanding of regulatory and legislative framework relating to CLs
- Fluency in local language; competence in business / technical English (written and verbal)
- Integrity
Preferred:
- Project management skills
- Clinical research experience (understand clinical research including trial design and implementation), analytical skills and statistical knowledge
- Experience in delivering team training
- Medical writing experience – published articles or written scientific abstracts
- Relevant clinical education experience
Assignment and Planning of Work
- Activities and work assignments generated by Professional in accordance with EMA Professional Partnering Strategy and in liaison with the General Manager of UK.
Other Working Relationships
(The main internal and external relationships connected with the job, other than immediate manager and subordinates)
-
- Members of the UK & Ireland PAF and PAC teams and Management Team
- Members of the EMA Professional and Medical Affairs Team
- UK Sales team
- Regulatory and QA, EMA
- Customers (Key Accounts, ECPs)
- Health and regulatory authorities; local Government Affairs
- Professional bodies, educational centres, key opinion leaders.
- Key local researchers
- R&D/Claims
Problems / Key Features
(The most complex and difficult parts of the job and other significant features not covered elsewhere)
- Time management and focus on key job roles.
- Setting aside time to develop links with Key Opinion Leaders (KOLs).
- Maintaining familiarity with all technical / clinical claims across product portfolio.
- Cross function teamwork with key stakeholders
- Ensuring substantiation of claims in all professional and marketing materials while supporting optimal messaging to help grow the business
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Wokingham
Organization: Johnson & Johnson Medical Ltd. - fka -Ethicon Ltd. (7355)
Job Function: Medical Affairs
Description
Job Title: Medical Affairs Manager UK & Ireland
Reports To: Professional Affairs Director UK & Ireland
Franchise/Department: J&J Vision Care, Professional Affairs
Location: Pinewood, Wokingham
Background Information
This member of the professional affairs team will strengthen the scientific, clinical and technical support to the local PAF team, the organisation and its customers, in addition to shaping the external environment to meet future business needs.
Job Purpose
The Medical Affairs Manager’s primary role is to ensure robust scientific review and claims substantiation of all customer facing materials, ensure full regulatory and health care compliance through liaison with regulatory, educational and compliance bodies, and provide technical support to customers, sales and customer services. In addition this role will develop and execute plans to shape local external environment to support future business needs. They will be the key liaison between Universities and will also be called upon to write publications, clinical conference materials and other clinical flashcards. This will be achieved by means of the roles and responsibilities set out in sections 3 and 4.
Key Dimensions
- To keep up to date with the latest research and advancements within vision care correction.
- To understand the interaction between Professional Affairs, TVCI and marketing.
- To understand the professional, technical and clinical support needed by key accounts, key independent customers, our sales force and customer services.
- To understand technical, clinical and performance attributes of JJVC products, key study results and claims, and differences with key competitor products.
- To be aware of the regulatory framework under which JJVC products are sold.
- To understanding the legal and Health Care Compliance policies.
- To understand the clinical trials process for company sponsored and investigator initiated trials and the generation of new information and claims
Main Job Role
- Scientific review and copy clearance ensuring claims substantiation, regulatory compliance of all professional and marketing materials.
- Develop and maintain strong links to regulatory authorities, competent bodies and professional bodies to help shape future environment.
- Lead medical vigilance investigation and reporting
- Crisis / issue management.
- Raise scientific profile and optimise awareness of JJVC and products through written and verbal communications
- Aid optimisation of customers’ and key influencers’ awareness of the technical and clinical benefits of JJVC products, and compared to competitors’ products
- Presentations at local conferences and customer-facing meetings and responding to unsolicited questions as required
- Publication plan execution with effective leveraging of articles generated by EMA Medical Affairs or published in other local markets.
- Generate new clinical articles (with KOL/PAC)
- Expert on clincial and technical product/category related questions for internal teams (marketing, customer services and sales organisation) and ECPs
- Provide guidance to the organisation on learnings from external scientific publications and clinical conferences
- Sales team training and new recruits technical training
- Foster excellent relationships with key opinion leaders and develop programme to ensure support of JJVC
- University liaison
- Execute pre- and post- launch performance surveys of new and existing products (fit panels) with support from EMA MRD/CSI and Medical Affairs
- Assist EMA Medical Affairs with local company sponsored clinical trials for generation of new information and claims and aid in site selection and field support for studies
Qualifications
Knowledge / Experience / Skills required
Essential:
- Qualified eye care practitioner (optometrist, contact lens optician or ophthalmologist)
- Minimum 5 years experience in contact lens practice
- High level of interest and technical knowledge of contact lenses
- Demonstrable experience of working successfully in a team
- Good presentation skills
- High verbal and written communication skills
- Computer skills including Powerpoint, Word and Excel
- Understanding of regulatory and legislative framework relating to CLs
- Fluency in local language; competence in business / technical English (written and verbal)
- Integrity
Preferred:
- Project management skills
- Clinical research experience (understand clinical research including trial design and implementation), analytical skills and statistical knowledge
- Experience in delivering team training
- Medical writing experience – published articles or written scientific abstracts
- Relevant clinical education experience
Assignment and Planning of Work
- Activities and work assignments generated by Professional in accordance with EMA Professional Partnering Strategy and in liaison with the General Manager of UK.
Other Working Relationships
(The main internal and external relationships connected with the job, other than immediate manager and subordinates)
-
- Members of the UK & Ireland PAF and PAC teams and Management Team
- Members of the EMA Professional and Medical Affairs Team
- UK Sales team
- Regulatory and QA, EMA
- Customers (Key Accounts, ECPs)
- Health and regulatory authorities; local Government Affairs
- Professional bodies, educational centres, key opinion leaders.
- Key local researchers
- R&D/Claims
Problems / Key Features
(The most complex and difficult parts of the job and other significant features not covered elsewhere)
- Time management and focus on key job roles.
- Setting aside time to develop links with Key Opinion Leaders (KOLs).
- Maintaining familiarity with all technical / clinical claims across product portfolio.
- Cross function teamwork with key stakeholders
- Ensuring substantiation of claims in all professional and marketing materials while supporting optimal messaging to help grow the business
Primary Location:Europe/Middle East/Africa-United Kingdom-England-Wokingham
Organization: Johnson & Johnson Medical Ltd. - fka -Ethicon Ltd. (7355)
Job Function: Medical Affairs