Position Summary
The International Medical Review Lead reports into the Sr. Director Global Medical Information and Medical Review (GMI-MR) and is responsible for leading the Medical Review function as part of the Medical, Legal, and Regulatory (MLR) review committee.
This individual serves as the Medical delegate, ensuring medical accuracy and medical veracity of promotional and non-promotional materials.
The International Medical Review Lead will liaise with functional leaders to operationalize robust and compliant procedures for the MLR review process.
Additionally, the individual in this role serves as the departmental liaison between headquarters-based Global Medical Information and local countries in the provision of the medical information service in the International region.
This includes overseeing service operations in these regions as it pertains to ensuring the provision of high quality, timely, medical information and technical information / specifications, on request, to external Physicians, Nurses, Pharmacists, other Health Care Professionals (HCPs), patients, caregivers and other , and internal stakeholders either directly or through contracted medical information service providers / contact centers.
The employee carries out this role by developing an expert understanding of product data and labeling, associated disease states, relevant literature, treatment guidelines, competitor information, and marketing strategies and tactics across Alexion's therapeutic areas.
The position requires a high level of expertise in the disciplines of medical review and medial information, scientific acumen, and cross-functional collaboration, including working closely with GMI-MR team members, as well as regional Medical Affairs, Commercial, Legal, Regulatory, Quality, and Drug Safety.
Excellent oral and written communication skills, customer focus, and teamwork are essential for this role. Previous participation in audits is a plus.
Direct Reports : External consultants / vendor currently.
Principal Responsibilities
Medical Review
Works collaboratively and develops good working relationships with the Global Medical Affairs Lead (GMALs) and Medical Directors to ensure alignment of company medical strategy.
This includes escalating materials accordingly when guidance is required.
Serves as the medical delegate on International Medical, Legal, and Regulatory (MLR) review committee, which is responsible for review and approval of all promotional and medical / scientific materials containing information on Alexion's marketed products and compounds in development, as well as the corresponding disease states developed for International markets.
Reviews materials and ensures data included are accurate, within context, and presented in a fair / scientifically balanced manner.
Verifies the substantiation of all claims and comparisons. Determines acceptability of references, advises on whether claims are consistent with appropriate approved label, and ensures that the piece is relevant and of utility for the target audience.
Oversees and manages external consultants who support Medical Review in the International MLR function.
Participates and actively contributes in key strategic meetings led by marketing, regulatory or access and ensures early sharing of medical content as per MLR guidance.
Advises on materials and events designed and produced by International Marketing and Medical Affairs teams to ensure compliance with company policies and global standards for ethical promotion and scientific interactions.
Supports International Marketing and Global Medical Directors through guidance and provision of information on company products, brand messages and claims that are in compliance with regulatory requirements and applicable external codes of practice, including but not limited to the EFPIA (European Federation Pharmaceutical Industries and Associations) and IFPMA (International Federation of Pharmaceutical Manufacturers) codes.
Ensures standards for promotional claims and non-promotional product information sharing, ensuring promotions and communications adhere to regulations and support appropriate use of products.
Medical Information
Assists Global Medical Information in identifying regional medical information needs per country and working in collaboration with those affiliates to optimize delivery of MI service : Assist Global team in handling call center vendor escalations of medical information inquiriesMaintain and update the Medical Information Letter Library in accordance with label updates, as requested by the Global Medical Information Therapeutic Area teamsEstablish and / or maintain applicable regional and / or local MI procedural documents in alignment with other local and global SOPsResponsible for oversight of language translation requirements of documents per company or local regulations (ie.
global and local SOPs, employee training, etc.)Responsible for working collaboratively with IT, Telephony and vendors to ensure business continuity procedures are in place and tested
Partner with affiliates and Global Medical Information to represent function in regional audits and inspections; participate in required activities before, during and post-inspections
Lead oversight of external partnerships through transitioning medical information processes to a third-party vendor partner, ensuring appropriate and timely medical information support and process training is initiated and maintained for regions falling under this domain.
General
Assists in the training and development of newly hired or junior personnel supporting International Medical Information or Medical Review as applicable.
Works under the guidance of the GMI-MR team; works collaboratively with the team supporting US medical review and approval of promotional and medical materials and is willing to support Global Medical Information activities.
Provides support to broader activities in Medical Communications as necessary, including Medical Education and Scientific Communications.
Achieves and maintains compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Alexion are carried out with the best industry practices and the highest ethical standards.
Essential Qualifications
Advanced bioscience or pharmacy / medical qualification.
Minimum of 10 years of experience in the pharmaceutical industry within Medical Affairs; experience working on a cross-functional Medical, Legal, Regulatory (MLR) review committee.
Experience reviewing promotional materials (consumer, HCP, payor, launch) and non-promotional / medical materials
Strong scientific acumen and ability to grasp complex therapeutic areas, including rare diseases or orphan drug products
Sound knowledge of international and EU medical compliance regulations, codes of practice and their practical application
Strong multitasking, project management and organizational skills
Solution-oriented, positive attitude and excellent interpersonal skills; as well as oral and written communication skills
Experience working as part of a multi-national team
Ability to work cross-functionally with Marketing, Legal, Regulatory, Medical Affairs, Clinical Development and other stakeholders who submit content through the review process
Ability to travel to meetings / conferences (domestic and international) approximately 20% of the time
Preferred Qualifications
Doctoral degree (PharmD, MD, Ph.D.)
5 years of relevant experience in the medical review of promotional and scientific materials
2 years of medical information experience
2 years of formal management experience
Experience leading medical affairs initiatives for a product launch
Training or past experience in assigned therapeutic area(s) or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapies
Experience in developing work practice documents, SOPs and effective training materials
This is an office based role 3 days per week.
To apply please submit your CV in English.
Date Posted
02-may-2024
Closing Date
26-jun-2024
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.
The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.
Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact .
Alexion participates in E-Verify.
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