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The Medical Advisor (MA) is a member of the Medical department. The MA represents a cross-functional therapeutic and product expert. Her / his role focuses on the development and execution of the clinical drug development strategy, along with scientific support for drug-related regulatory activities.
The challenge!
Main Accountabilities
- Execute the clinical strategic global development plans through the management of the assigned product.
- Represent the medical department in meetings such as Advisory Boards, groups of medical experts, safety committees, regulatory bodies, etc.
- Perform internal product-related and disease-specific medical training.
- Create and update the Clinical Development Plan for the assigned product.
- Design and review study protocols (and amendments) and master ICF.
- Review and ensure the correct execution of medical activities study plans (data review plan, medical management plan, etc.)
- Execute medical reviews related to clinical trials.
- Lead periodic deviation review meetings.
- Prepare and release the Clinical Study Report.
- Support scientific publication writing and review for journals and congresses.
- Review Module 4 and 5 of the Dossier.
- Develop medical responses to deficiency letters from the Dossier team.
- Become a recognized expert in nominated therapeutic areas and contribute to product development teams.
- Advise on medical, regulatory, and clinical matters related to the product portfolio.
- Maintain up-to-date knowledge of the therapeutic area and competitive environment.
- Prepare scientific evidence to communicate product benefits in pipeline reviews.
- Represent the company in presentations to experts and regulatory bodies.
- Engage with Medical Experts and investigators for new trials and collaborations.
- Mentor newcomers as requested.
- Support medical queries within the company.
Pre-Launch activities
Interpret medical data and identify communication strategies for stakeholders.Attend and represent the medical department at relevant meetings.What do you need?
Education : Medical Degree (PhD is a plus)Languages : Fluent in Spanish and EnglishExperience : At least 1 year in clinical or research settingsKnowledge : Ability to assimilate information quickly, present clinical data clearly, and discuss statistical and clinical relevance.Travel : Willingness to travelPersonal Skills : Organizational, proactive, flexible, decision-making, detail-oriented, excellent interpersonal and communication skills, leadership qualities.Additional Benefits : Flexible start time, benefits and savings club, training and language platforms, wellness services, development and mobility policies.
Selection Process :
Initial contact via phone or email.In-person or virtual interviews, possibly with assessments.Receive feedback and updates throughout the process.Commitment to Equal Opportunities
We promote equality and do not discriminate based on ethnicity, religion, age, sex, nationality, marital status, sexual orientation, gender identity, disability, or other personal circumstances.
Seniority level
Mid-Senior levelEmployment type
Full-timeJob function
OtherJ-18808-Ljbffr
J-18808-Ljbffr