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Medical Affairs Associate Director

Reference:BCALSP-541677
Location: Dublin
Qualification:Professional
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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Our client is a top 10 biotech who are seeking a medical doctor to join their team of Medical Advisors in south Dublin. The company has a bulging pipeline which this role will support from a Clinical Trial, Sales and Marketing and Medical Expertise perspective.

Superb package and team environment are on offer. The Manager is a highly-respected individual who places huge emphasise on their team and staff development.

REQUIREMENTS

EXTERNAL SUPPORT 45%

Scientific leadership
(i) Scientific Leader (SL) Engagement
To act as a medical resource for internal and external customer, review and oversee the dissemination of medical information to HealthCare Professionals (HCPs) and the public.
Drive the development of strong professional relationships with SLs through 1:1 interactions to build a thorough understanding of customer needs and the competencies required to serve them
Conduct Advisory Boards as required to help inform strategic priorities
Promote the global clinical development programme locally, assist SLs with development of Local Clinical Evaluations and Investigator Initiated Studies , enhance the company's reputation as a partner of choice for HCPs
Provide non-product related education to HCPs on areas of expertise within the discipline of pharmaceutical medicine
(ii) Clinical Operations/Studies
Collaborate closely with Clinical Trials operations to provide suggestions for clinical research (investigators, objectives, design, sites, studies etc)
Work closely with Clinical Trials operations in the management of local sites involved in clinical studies
Liaise with Regional Medical Affairs Team to contribute to regional strategies around LCEs and IISs
Act as country point of contact for LCEs and IISs
Act as point of contact and work closely with investigators during the conduct of LCEs, IISs, epidemiological studies, registries etc as appropriate
INTERNAL SUPPORT 45%
(iii) Medical Information
Liaise with outsourced medical information provider to ensure quality and seamless response to customer medical information queries
Provide timely, tailored responses to customers’ requests where not available through outsourced medical information provider
(iv) Medical/Scientific Strategy
Draft and execute the Country Medical Affairs Plans for key products
Participate in Regional Medical Affairs Teams meetings and provide high level technical and medical input into regional strategic and tactical planning
(v) Sales and Marketing
Provide training to sales and marketing staff to ensure medical knowledge of products and therapy areas is accurate and in compliance with legislation and the IPHA Code of Marketing Practice
Provide sales and marketing colleagues with relevant information on new studies, competitor data, issues etc.
Provide sales reps. with information on new studies, competitors, issues etc
Provide scientific support to help Business Unit achieve its sales and marketing objectives
Participate in profit planning process as required by the Business Unit
Manage Life Cycle Management (LCM) budget.
Collaborate closely with marketing colleagues during the development of promotional materials to ensure optimal use of data to support core product claims
(vi) Medical/Legal Review and Compliance
Review and sign-off to ensure compliance of promotional materials and company sponsored activities such as local promotional meetings and events with local SPCs, legislation and IPHA code and global company policies.
Support Business Practice and Compliance Officer as required
Execute all activities according to applicable compliance policies and procedures.

(vii) Pharmacovigilance & Regulatory
Facilitate reporting of adverse events by providing adequate training to colleagues on the reporting of AEs
Review and approve all changes to SmPCs, PILs etc by Regulatory Affairs
Regular training of colleagues on SPC changes
(viii) Market access/reimbursement
Support market access colleagues in HTA applications
Use scientific and medical expertise to support reimbursement by demonstrating the added clinical value of the company's therapies.
Collaborate with market access to facilitate the inclusion of the company’s products in hospital formularies, local therapeutic guidelines etc
Participate in strategic defense of the company’s products with key decisions makers
(ix) External Affairs
Support External Affairs department in patient advocacy initiatives
Use scientific and medical expertise to support the company and its products in interactions with local media (Press, TV and radio)
Review and approve press releases
Continuing Professional Development – 10%
Continually develop product and therapy area(s) expertise through ongoing literature reviews, national and international congresses attendance, training courses etc
Develop expertise in new therapy areas as dictated by business requirements
Education and Requirements
MB BCh Essential
MSc / PhD, Research experience preferred
MBA or other business qualification is an advantage.
All therapeutic areas are encouraged to apply.




If you would like further Information you can contact the recruiter directly:



Brian Christensen | Tel: +353 (0) 1 685 4747







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