Medical Advisor

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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 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

What do you need?

What will the Selection process be like? ️

Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels.

Prepare well! We will continue with an in-person / virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test.

Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.

Do you think this offer is not for you?

COMMITMENT TO EQUAL OPPORTUNITIES

Our group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3 / 2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Other

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