Responsable Validation médicale h/f // CDD 12 mois

MSD

2mo ago

Applications are closed

Job
Full-time
Senior Level
Research & Development
Healthcare

Requirements

Docteur en Pharmacie
Anglais courant lu, parlé, écrit indispensable
Connaissance de nos médicaments et de leurs aires thérapeutiques
Connaissance de la réglementation pharmaceutique sur la publicité
Connaissance des outils digitaux
Connaissance en Assurance qualité
Expression claire et compréhension des besoins des différents clients internes et externes
Capacités de communication transparente écrite et orale, de négociation et de diplomatie
Capacité à formuler des recommandations au management
Compréhension des objectifs de l’entreprise
Esprit d’équipe développé
Capacité à fournir de façon constante des résultats de qualité dans les délais impartis. Respect des engagements. Sens des responsabilités
Adaptabilité pour une gestion optimale du travail. Connaissance et maitrise des outils informatiques nécessaires.

Responsibilities

Assurer la validation médicale du matériel digital et imprimé promotionnel pour notre vaccin sous la responsabilité du titulaire à destination des Professionnels de santé et non promotionnel à destination du Grand Public ou des Professionnels de Santé, dans le respect de la réglementation française, des procédures et de l'éthique de notre entreprise.
Assurer le contrôle interne du respect de nos procédures inhérentes à nos activités de validation médicale et le suivi des CAPA correspondantes, en coordination avec le département assurance qualité.
Evaluer et approuver les projets de matériel promotionnel à destination des professionnels de santé et du Grand Public.
Evaluer et approuver les projets de matériel d’information médicale non promotionnels, et des contenus digitaux publiés sur des sites Internet destinés au Grand Public.
Communiquer aux collaborateurs terrain en charge de l’information promotionnelle et aux équipes Marketing les informations relatives au bon usage du vaccin sous la responsabilité du titulaire, telles que les rectificatifs d’AMM, les Avis de la Commission de la Transparence, les Recommandations de Bonnes pratiques des autorités de santé en vaccinologie afin d’assurer leur mission de favoriser le bon usage de nos médicaments auprès des professionnels de santé et in fine des patients.
Evaluer et appouver les documents de formation «produit» à destination des collaborateurs réalisant des activités d’information promotionnelle par démarchage ou prospection.
Effectuer et coordonner les contrôles internes relatifs à nos activités ainsi que le suivi des CAPA, avec des indicateurs qualité, en coordination avec le département assurance qualité.
Assurer la coordination avec les audits internes diligentés par le service et le département qualité, et les audits externes et inspections, tel que l’audit annuel de la HAS.
Assurer en niveau 3 sur demande du Directeur du département la revue et l’approbation de FAQ ou réponses standards à des questions d’information médicale sur notre médicament.
Renforcer la confiance des professionnels de santé en la valeur du vaccin de notre entreprise par l’approbation d’un matériel d’information médicale pertinent, éthique, favorisant leur prescription dans le respect du bon usage, conforme au plan.
Les projets proviennent des équipes Marketing, training, communication avec lesquels le titulaire travaille en étroite collaboration.
Contribuer au respect de la compliance et à la réputation de nos laboratoires.

FAQs

What is the main responsibility of the Responsable Validation médicale in this position?

The primary responsibility is to ensure the medical validation of promotional and non-promotional digital and printed materials related to vaccines, while adhering to French regulations, company procedures, and ethical standards.

What qualifications are required for this role?

A Doctor of Pharmacy degree is required, along with proficiency in English (reading, writing, and speaking), knowledge of pharmaceutical regulations regarding advertising, and familiarity with digital tools.

Is experience in quality assurance necessary for this role?

Yes, knowledge of quality assurance processes is required as the role entails ensuring compliance and quality control of validation activities.

How does this position interact with other departments?

This position collaborates closely with Marketing, training, and communication teams to review and approve materials that promote the vaccine to healthcare professionals and the public.

What types of materials will the Responsable Validation médicale be evaluating?

The evaluation will include promotional materials for healthcare professionals, non-promotional medical information for the public, and training documents for promotional activities.

Are there specific internal controls involved in this role?

Yes, the role includes executing and coordinating internal controls related to validation activities, as well as tracking corrective and preventive actions (CAPA) in collaboration with the quality assurance department.

What is the work arrangement for this position?

The position offers a hybrid work arrangement, which includes both remote work and on-site duties.

Is knowledge of the company’s products important for this role?

Yes, understanding the company's medications and their therapeutic areas is crucial for effectively validating medical communications and ensuring compliance.

What is the duration of the contract for this position?

The contract for this position is a fixed term of 12 months.

Are there any travel requirements for this role?

There are no specified travel requirements listed for this position.

MSD

We aspire to be the premier research-intensive biopharmaceutical company.

Science & Healthcare

Industry

10,001+

Employees

1891

Founded Year

Mission & Purpose

MSD, also known as Merck & Co. Inc. in the United States and Canada, is a global pharmaceutical company that focuses on discovering, developing, and delivering innovative healthcare solutions. They research and develop a wide range of prescription medicines, vaccines, biologic therapies, and animal health products. MSD's ultimate mission is to improve and save lives by addressing unmet medical needs and advancing healthcare worldwide. Their purpose is to develop innovative medicines and therapies that tackle diseases and conditions affecting individuals across the globe, with a strong emphasis on scientific excellence, patient-centricity, and ethical business practices. MSD strives to make a meaningful impact on public health by providing access to safe, effective, and high-quality healthcare solutions, while also contributing to the broader advancement of medical knowledge and healthcare systems

Culture & Values

Patients first
We are all accountable for delivering high quality products and services. We aspire to improve the health and wellness of people and animals worldwide, and to expand access to our medicines and vaccines. All of our actions must be measured against our responsibility to those who use or need our products.
Respect for people
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, safety and teamwork of our employees. We work to create an environment of mutual respect, inclusion and accountability. We reward commitment and performance and are responsive to the needs of our employees and their families.
Ethics and integrity
We are committed to the highest standards of ethics and integrity. We are responsible to all of our stakeholders: employees, patients, customers, distributors and suppliers, shareholders, and the communities we serve worldwide. We do not take professional or ethical shortcuts.
Innovation and scientific excellence
We are dedicated to the highest standard of innovation and scientific excellence. Our research is guided by a commitment to improving health and quality of life. We strive to identify and meet the most critical needs of patients and customers through continuous innovation across all areas of our business.