Director, Global Medical Information And Medical Review, Dublin

Last update 2024-07-12
Expires 2024-08-12
ID #2224654468
Director, Global Medical Information And Medical Review, Dublin
Ireland, Dublin, Dublin,
Modified July 4, 2024


This is what you will do: The Director of Global Medical Information and Medical Review leads the development and transfer of intellectual capital that enhances the safe and appropriate use of Alexion products to healthcare professionals and patients world-wide.

This person is accountable for the execution of medical information and medical review activities for assigned therapeutic area(s), as well as gives and implements department strategic imperatives and objectives.

The Director is accountable for aligning global medical information pre- and post-launch plans with internal constituents in Medical Affairs, Commercial, and Clinical Development Teams.

Success of this individual is highly dependent on the ability to collaborate cross-functionally and understand business strategy.

In addition, the Director will provide essential medical and scientific expertise, review, advisement and oversight to support development of high quality promotional and medical materials, internal training materials, and communications as part of the Promotional Review Committee (PRC) and Medical Material Review (MMR) Committee.

The employee carries out this role in accordance with departmental SOPs, corporate policy and other legal and regulatory requirements.

You will be responsible for: Leading planning, prioritization, and execution in alignment with internal collaborators e.g., Global Medical Affairs, Commercial, Clinical Development) ensuring product launch preparedness in the dissemination of medical information.

Developing / maintaining current, broad, and in-depth knowledge of pathophysiology, pharmacotherapy, and clinical outcomes associated with assigned Alexion products and disease states.

Leading the development, review and approval of medically accurate, up-to-date, and timely intellectual capital (e.g., medical information response documents, frequently asked questions) addressing the global scientific community’s knowledge gaps in disease / diagnosis, product information and clinical data in order to ensure consistency in scientific exchange by world‑wide Medical Affairs personnel in a compliant manner.

Training and mentoring Associate Directors, Managers, Fellows and third-party contact centre team to ensure alignment with operational objectives, excellence in execution, and maintenance of quality performance. Representing medical function in the Medical & Promotional Review Committees and ensures scientific / medical / clinical accuracy, relevance and completeness of data and that promotional claims within materials are adequately supported by data.

Leading / directing medical information booth activities on behalf of medical personnel at professional scientific meetings; including ensuring adequate staffing levels, medical information resources are in-date, cross-functional colleagues are trained, and post-congress reports are completed within a timely manner.

Providing medical / scientific expertise to commercial teams for appropriate disease and product claims development.

Providing mentorship on ethical, legal and regulatory standards for product promotion and scientific exchange.

Developing / maintaining current, broad, and in-depth knowledge of regulatory and advertising compliance requirements / limitations applicable to promotional and nonpromotional materials; as well as responding to unsolicited requests for medical information.

Assisting in the development / maintenance of departmental Policies, Standard Operating Procedures (SOPs), WPDs (Working Practice Documents), and Work Instructions (WIs).

You will need to have: Advanced scientific degree in pharmacy (Pharm D) or related science (Ph D, MD) with 7 years of medical information or medical communications experience in the pharmaceutical / biotech industry Thorough knowledge of the regulatory and compliance requirements / limitations applicable to medical information, as well as advertising / promotional and non-promotional pharmaceutical materials Experience leading medical information or medical communication initiatives for a product launch Experience in developing work practice documents, SOPs and effective training materials Excellent written and verbal communication skills Demonstrated ability to achieve aligned objectives in a matrixed environment Teammate in a multidisciplinary, cross-cultural environment, high level of flexibility Strong skills in project planning, courageous/challenging decision-making, problem-solving, and negotiating towards mutually beneficial outcomes Highly proficient with Microsoft Office Suite Ability to travel to meetings / conferences (including internationally) approximately 20% of the time The duties of this role are generally conducted in an office environment.

As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.

We would prefer for you to have: Experience providing medical information/medical communication support within a function5 years of relevant experience in review/editing promotional or scientific materials Experience developing (or overseeing the development of) materials applied by Medical Affairs in the context of scientific exchange Training or experience in assigned therapeutic area(s) or rare-disease, nephrology, haematology, oncology, neurology, enzyme-replacement therapies Date Posted03-Jul-2024 Closing Date03-Aug-2024 Our mission is to build an inclusive and equitable environment.

We want people to feel they belong at Astra Zeneca and Alexion, starting with our recruitment process.

We welcome and consider applications from all qualified candidates, regardless of characteristics.

We offer reasonable adjustments/accommodations to help all candidates to perform at their best.

If you have a need for any adjustments/accommodations, please complete the section in the application form.

Job details:

Job type: Full time
Contract type: Permanent
Salary type: Monthly
Occupation: Director, global medical information and medical review

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