Requirements: English
Company: mAbxience
Region: Madrid , Community of Madrid
About the job
Position: Medical Advisor
Location: Madrid .
Want to know more?
The Medical Advisor (MA) is a member of the Medical department. The MA represents a cross-functional therapeutic and product expert. Her/his role its focus on the development and
execution of the clinical drug development strategy together with the scientific support to drug related regulatory activities.
The challenge!
Main Accountabilities
- Execute the clinical strategic global development plans through the execution and management of the of the assigned product.
- He/she represents the medical department in meetings such as Advisory Board, groups of medical experts, safety committee, regulatory bodies, etc.
- Perform internal product-related and disease medical training.
- Create and update the Clinical Development Plan of the assigned product.
- He/she is responsible for final design and review of study protocols (and its amendments, if any) and master ICF.
- He/she is responsible of the review and correct execution of the medical-activities study plans (data review plan, medical management plan, data safety monitoring board plan, statistical analysis plan, medica! data review plan, etc.)
- Execute the study medical review related to trial.
- Execute the periodic deviation review meeting.
- He/she is responsible fer the preparation and release of the Clinical Study Report
- Support the writing and review of the scientific publications to be sent to medical journals and/or congresses.
- Perform the review for the Module 4 and 5 in the Dossier.
- Develop the medical response to deficiency letters from the Dossier Expertise and Medical support
- To be recognized as a company expert in the nominated therapeutic areas and provide input into all related product development teams.
- Provide advice across the company on medical, regulatory and clinical matters and activities relating to assigned product portfolio.
- Develop and maintain up-to-date knowledge including the competitive environment of the assigned therapy area.
- Prepares the medical and scientific evidence to communicate the benefits of product portfolio to the market in the pipeline review meeting.
- Represent the company via presentations to groups of experts and regulatory bodies.
- Engage Medical Experts and investigators in new clinical trials, identifying partners for future research collaboration, Key Opinion Leaders (KOLs) in Disease Area of research.
- Mentoring newcomers as requested by the medical department managers.
- Support medical queries from other departments within the company, as demanded.
Pre-Launch activities
- Provide valid and timely interpretations of medical data from medical research in the assigned therapeutic a rea and identify appropriate communication strategy for external and internal stakeholders.
- Development, attend and represent the medical department at appropriate meetings (advisory board meetings, investigator meetings, KOL meetings, CME, companys meetings, etc.)
What do you need?
- Education: Education: Grade of Medicine (PhD is a big plus)
- Languages: Fluent Spanish and English.
- Experience (years/area): At least one year of clinical or research experience.
- Specific Knowledge: Demonstrable thirst for knowledge with an ability to assimilate information quickly, present clinical data clearly and concisely and discuss the statistical and clinical relevance in line with key messages.
- Travels: Willingness to travel.
- Personal skills: Strong organizational, planning and prioritization skills. Costumer oriented personality. Proactive, flexible, decision making and detail oriented. Ability to adapt in a fast-paced environment. Excellent interpersonal skills, working effectively as a team and willing to work in an open and multicultural company. Ability to perform database/literature searches. Clear and effective written/verbal communication skills. Management and leadership skills.
Our benefits!
- Flexible start time from Monday to Friday (full-time).
- Permanent contract.
- Attractive salary package.
- Life and accident insurance.
- Ticket restaurant
- On-site medical service
- Benefits and Savings Club.
- Training and language learning platform
- Wellness platform with unlimited free psychologist sessions
- Cabify transportation service for employee use
- Development plans, internal mobility policy.
- Many more!