Total 20 job vacancies by MSD

Job Description

Main Responsibility

• The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  The clinical research physician is expected to address issues/questions raised.
• Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol.  
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs, and review protocol deviation and answer protocol related questions during study implementation phase.
• To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair, and marketing and regulatory affair.
• The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

Requirements

• Master Degree and above in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable.
• Be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. 
• The candidate should have a strong leadership, excellent written and oral communication skills, and project management skills.
• Strong capability of work prioritization and deliver results with parallel multiple tasks.
• Excellent language skills in both English and Chinese (fluent in verbal and written).

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with Standard Operating Procedures. Works with management to maintain the consistent execution of quality global procedures and monitors workload and resource allocation. Supports the comprehensive development of junior supervised staff and encourages effective interaction of Data Management Center staff with business partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of Global Data Operations deliverables at the trial level.

Education:

At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

Knowledge and Skills:

Four years’ experience in data management, medical research, or database design and development is preferable. Extensive start-up and in-life data management experience is required. Knowledge of database structures and available tools to manage, extract, and report data is preferred. Fluent Oral and written English language skills. Knowledge of applicable regulations and policies. Proficient overall working knowledge of the clinical development process.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.

WHAT YOU WILL DO

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. The CRM could be responsible for a particular study for several countries in a cluster.

Responsibilities include, but are not limited to:

• Main Point of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).

• Responsible for project management of the assigned studies: pro-actively plans, drives and tracks execution and performance of deliverables/timelines/results to meet country commitments from feasibility and site selection, recruitment, execution and close out.

• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally.

• Reviews Monitoring Visits Reports and escalates performance issues and training needs to CRA manager and/or functional vendor and internal management as needed. o Performs Quality control visits as required.

• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTC, CRAs and COM).

• Responsible for creating and executing a local risk management plan for assigned studies.

• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.

• Escalates as needed different challenges and issues to TA Head/CRD/CCQM and or CTT (as appropriate).

• Identifies and shares best practices across clinical trials, countries, clusters.

• Responsible for collaboration with functional outsourcing vendors, investigators, other external partners in assigned studies.

• Country POC for programmatically outsourced trials for assigned protocols.

• In this position, you will be responsible for building business relationships and representing our company to investigators as a customer-facing role.

• Serves local business needs as applicable in their country (if delegated can sign contracts and manage budgets).

• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TAH and Regional Operations.

• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with GHH as needed.

CORE Competency Expectations:

• Knowledge in Project Management and site management.

• Strong organizational skills with demonstrated success required.

• Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies and commitments with the support, oversight and supervision of the TA Head or CRD.

• Requires strong understanding of local regulatory environment.

• Strong scientific and clinical research knowledge is required.

• Strong understanding of clinical trial planning, management and metrics is essential as well as the ability to focus on multiple deliverables and protocols simultaneously.

• Experience functioning as a key link between Country Operations and Clinical Trial Teams

• Communicates effectively and builds a collaboration spirit in a remote/virtual environment and across countries, cultures and functions.

• Ability and skills to manage resource allocation, processes (and controls), productivity, quality and project delivery.

• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.

• Strategic thinking.

• Ability to work efficiently in a remote and virtual environment.

• Understand cultural diversity.

• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.

Behavioral Competency Expectations:

• Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our Research Labs (MRL), Global Clinical Development (GCD) and GCTO.

• Ability to identify problems, conflicts and opportunities early and lead, analyze and prepare mitigation plans and drive conflict resolution is critical.

• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include: 1) low patient recruitment, 2) inadequate staff to meet business needs, 3) performance or compliance issues, 4) working with regulatory issues and the broader organization, and 5) resolution of conflictive situations.

• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Experience Requirements:

• Required: • At least 9 years of clinical research experience, including at least 2 years of project or people management and 5 years of monitoring experience.​

​

​Educational Requirements:

• Required: • Bachelor degree in Science (or comparable)

• Preferred: • Advanced degree, (e.g., Master degree, MD, PhD).

Who we are

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

 

What we look for

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

En Strategy and Business Operations buscamos ser un socio indispensable para nuestras unidades de negocio, implementando iniciativas estratégicas corporativas a nivel subsidiaria y brindando servicio a las áreas de marketing y ventas.

El Market Research and Sales Force Effectiveness Manager tiene como principal objetivo liderar y gestionar estrategias, procesos y proyectos para optimizar la efectividad de nuestra fuerza de ventas y llevar a cabo investigaciones de mercado que impulsen el crecimiento y el éxito de nuestras marcas y productos.

Tendrá un rol clave en el análisis de conclusiones para brindar propuestas a las unidades de negocio, y debe ser capaz de gestionar múltiples tareas simultáneamente y mantenerse organizado bajo presión.

Responsabilidades:

• Gestionar y liderar al equipo de Sales Force Effectiveness, automatizando la analítica y optimizando procesos.
• Establecer KPIs y generar informes para respaldar la toma de decisiones basadas en datos y proporcionar recomendaciones estratégicas a los directores de Unidad de Negocio.
• Implementar nuevos módulos y funcionalidades en Salesforce, asegurando una correcta carga de solicitudes y seguimiento.
• Monitorear y evaluar el desempeño de las estrategias de ventas y la cobertura de los clientes objetivo, identificando oportunidades de mejora y desarrollando soluciones efectivas.
• Promover las mejores prácticas en KPIs de SFE, incentivos de ventas, segmentación y capacidades de ventas; alineado a las pautas locales y globales.
• Participar en equipos multifuncionales y proyectos, aportando soluciones y conocimientos expertos en participación de clientes, estructura de SFE y datos de mercado.
• Garantizar una implementación exitosa de los requisitos del negocio en Salesforce, optimizando las configuraciones y asegurando un flujo de trabajo eficiente.
• Gestionar de manera efectiva la comunicación y brindar capacitación a los usuarios sobre herramientas y sistemas de SFE.
• Supervisar y participar en estudios de mercado e investigaciones, aplicando técnicas de investigación y análisis de datos.

Requisitos

• Graduado de carreras en áreas relacionadas con Marketing, Admin. Empresas, Economía o campos afines.
• Experiencia previa en investigación de mercado, análisis de datos y gestión de procesos de Sales Force Effectiveness, preferiblemente en la industria farmacéutica.
• Conocimiento de técnicas de segmentación de mercado, KPIs de ventas y análisis de rendimiento de la fuerza de ventas.
• Capacidad demostrada para liderar y gestionar equipos, así como simplificar y automatizar procesos analíticos en colaboración con el equipo de Análisis de Datos
• Excelentes habilidades de comunicación interpersonal y capacidad para trabajar en entornos dinámicos de manera efectiva.
• Comprensión del negocio farmacéutico y conocimiento de las regulaciones de la industria.
• Ingles avanzado.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Main Responsibility

• The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  The clinical research physician is expected to address issues/questions raised.
• Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol.  
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs, and review protocol deviation and answer protocol related questions during study implementation phase.
• To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair, and marketing and regulatory affair.
• The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

Requirements

• Master Degree and above in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable.
• Be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. 
• The candidate should have a strong leadership, excellent written and oral communication skills, and project management skills.
• Strong capability of work prioritization and deliver results with parallel multiple tasks.
• Excellent language skills in both English and Chinese (fluent in verbal and written).

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Das Pneumo-Team in der BU Impfstoffe stellt die Impflinge und sämtliche Interessengruppen seines Umfelds (Ärzte, Apotheker, Großhandel, politische Entscheidungsträger, Kassen und auch Laien) in den Mittelpunkt.

Unsere Marketing-Mitarbeiter haben es sich zur Leidenschaft gemacht, unsere Medikamente und Impfstoffe Kunden auf der ganzen Welt zugänglich zu machen. Durch Nutzung von Methoden wie dem Digital Listening und Patientenanalysen können wir die Bedürfnisse unserer Kunden ermitteln und entsprechend abgestimmte Lösungen anbieten.

Dabei testen wir neue Marketing- und Vertriebslösungen und agieren funktionsübergreifend, datengesteuert und kundenzentriert. Wir entwickeln in crossfunktionalen Teams mit Hilfe von verschiedenen agilen Arbeitsmethoden maßgeschneiderte innovative Lösungen für unsere Kunden.

In der Position des (Senior) Brand & Customer Managers Vaccines Pneumo (m/w/d) gehört es zu Ihren Aufgaben, die Marketingstrategie, insbesondere für unseren Pneumokokken-Impfstoff, hauptverantwortlich mitzugestalten sowie selbständig Projekte zu entwickeln und durchzuführen.

Außerdem führen Sie in enger Abstimmung im Team und mit angrenzenden Funktionsbereichen, wie dem Außendienst, Communications, Medical, Marktforschung und Market Access, unseren Impfstoff zum Erfolg.
Dazu bringen Sie ein hohes Maß an Eigenverantwortlichkeit, sehr starke Teamorientierung und kreatives Denken mit. Ihre Rolle trägt maßgeblich zu der Entwicklung einer zukunftsorientierten, agilen Arbeitskultur bei.

Verantwortungsbereiche:

• Verantwortlich für die Entwicklung, Umsetzung und Tracking der Marketingstrategie

• Verantwortlich für die Definition und Implementierung eines geeigneten Communication Channel Mix mit Fokus auf einen integrierten Ansatz von Außendienst und weiteren (digitalen) Kanälen unter Berücksichtigung der Kundensegmentierung

• Verantwortlich für Optimierung und Implementierung des Omnichannel-Ansatzes

• Setzen klarer KPIs für das Team, um alle Aktivitäten am Kundenmehrwert auszurichten

• Umsatz-, Absatz-, Budgetplanung und -analyse, sowie Tracking

• Entwicklung, Implementierung und Monitoring von Kernelementen der Markenpläne

• Marktanalyse und Marktforschungs-Projekte mit Ableitung von geeigneten Maßnahmen

• Erstellung des Finance-Forecasts und des Unit-Forecasts als Basis für die Finanz- und Produktionsplanung des Unternehmens 

• Koordination und Führung von Agenturen

• Entwicklung, Erstellung und Bereitstellung von Aktivitäten und Materialien (on- und offline) für den Außendienst

• Effektive Kommunikation und Motivation des Außendienstes, Präsentation von Marketingplänen auf Außendiensttagungen sowie Aus- und Weiterbildung der Außendienstmitarbeiter

• Erstellung von Präsentationen und Durchführung von Business Reviews

Qualifikationen:

• Abgeschlossenes wirtschafts-/ naturwissenschaftliches Studium

• Mehrjährige Erfahrung im Produktmanagement in einem pharmazeutischen Unternehmen

• Umfassende Erfahrung im Umgang mit Marktzahlen/-analysen und bei der Erstellung von Forecasts

• Mehrjährige Erfahrung in der erfolgreichen Zusammenarbeit mit großen funktionsübergreifenden Teams

• Erfahrung im Außendienst wünschenswert

• Erfahrung in agilen Teams wünschenswert

• Strategisches und analytisches Denkvermögen, Organisationstalent, Entscheidungsfähigkeit, Kooperationsbereitschaft und sehr gute Teamfähigkeit

• Erfahrungen in digitaler Kommunikation und Kundenansprache (Internet, interaktive Webauftritte, Portale und Social Media)

• Gute PC-Kenntnisse im Bereich der üblichen Standardsoftware

• Sehr gute Präsentationsfähigkeiten, großes Talent beim Außendienst Begeisterung zu erzeugen und Kollegen zu motivieren

• Sehr gute Englischkenntnisse in Wort und Schrift

Unser Unternehmensbereich Humanmedizin hat sich der Ideologie „Patient First, Profits Later“ verschrieben. In diesem Bereich sind Experten aus folgenden Gebieten tätig: Vertrieb, Marketing, Market Access, digitale Analytik und kaufmännisches Management. Sie alle eint die Leidenschaft, unsere Medikamente Kunden auf der ganzen Welt zugänglich zu machen.

Wir sind stolz darauf, ein Unternehmen zu sein, das auf den Werten seiner vielfältigen, talentierten und engagierten Mitarbeiter aufbaut. Der schnellste Weg innovative Entwicklungen voranzutreiben ist, unterschiedliche Ideen in einer integrativen Umgebung zusammenzubringen. Wir bestärken unsere Kollegen darin, sachlich über ihre Vorstellungen zu diskutieren und Probleme gemeinsam anzupacken. Wir sehen uns als Arbeitgeber der Chancengleichheit und engagieren uns dafür, integrative, vielfältige Arbeitsplätze zu fördern.

Menschen mit Schwerbehinderung und ihnen Gleichgestellte werden bei gleicher Eignung bevorzugt eingestellt.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

No

Job Description

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

We are looking for a Regulatory Affairs Manager (m/f/d) to join our Local Regulatory Affairs team in our office in Munich. This is a permanent role.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Major Activities (may not be limited to):

• Manage and support timely and correct submission and approval of assigned New Marketing Authorization applications (MAA) and Supplemental Marketing Authorization applications (e.g. new indications, variations, renewals) in close cooperation internally with multiple departments on national, regional, and global level and close interaction with relevant regulatory authorities
• For new MAA and new major indications, design and implement local action plans to ensure proper product launch in line with local project plans
• For new MAAs and major indications manage and implement Early Access Programs (EAPs)
• Ensure timely and correct local implementation of all relevant approved Marketing Authorization applications in compliance with all applicable regulatory regulations as well as internal national, regional and global processes with regard to high quality German translation of the approved Product Information and artwork implementation and update of all relevant internal regulatory databases and archives, internal and external websites and compendia
• Support the agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new EU CT Regulation, in cooperation with RAE Liaison, and other internal stakeholders
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed
• Participates in establishing and maintaining of relevant SOPs to secure that the current regulations are complied with
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance

Qualification:

• Master’s degree in Pharmacy or other a relevant scientific discipline or equivalent
• Minimum of 5 years’ experience in a Regulatory Affairs Department, experience with relevant aspects of Regulatory Affairs activities, Regulatory Agency contact and experience in supervising others
• Familiar with local and EU legislation procedures and guidelines governing medicinal products and medical devices
• Experience in the translation and implementation of product information texts as well as with Market Access strategies
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to internal and external stakeholders
• Fluent in German and English
• Strong project management skills, including the ability to prioritize tasks, manage timelines, and deliver high-quality results under tight timelines
• Meticulous attention to detail, ensuring accuracy in regulatory documentation and compliance with all relevant standards and regulations
• Proficient in working in a modern digital and paperless environment utilizing MS Office tools and collaboration platforms and systems for documentation, analysis, and reporting, enhancing efficiency in regulatory processes
• Client-oriented approach and excellent relationship-building skills

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
People with severe disabilities and their equivalents will be given preference if they are equally qualified.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Description

We are looking for a Regulatory Affairs Manager (m/f/d) to join our Local Regulatory Affairs team in our office in Munich. This is a permanent part-time role (50%).

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Major Activities (may not be limited to):

• Manage and support timely and correct submission and approval of assigned New Marketing Authorization applications (MAA) and Supplemental Marketing Authorization applications (e.g. new indications, variations, renewals) in close cooperation internally with multiple departments on national, regional, and global level and close interaction with relevant regulatory authorities
• For new MAA and new major indications, design and implement local action plans to ensure proper product launch in line with local project plans
• For new MAAs and major indications manage and implement Early Access Programs (EAPs)
• Ensure timely and correct local implementation of all relevant approved Marketing Authorization applications in compliance with all applicable regulatory regulations as well as internal national, regional and global processes with regard to high quality German translation of the approved Product Information and artwork implementation and update of all relevant internal regulatory databases and archives, internal and external websites and compendia
• Support the agency interactions to ensure a seamless submission, assessment, and quick approval of the CTAs, according to the new EU CT Regulation, in cooperation with RAE Liaison, and other internal stakeholders
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed
• Participates in establishing and maintaining of relevant SOPs to secure that the current regulations are complied with
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance

Qualification:

• Master’s degree in Pharmacy or other a relevant scientific discipline or equivalent
• Minimum of 5 years’ experience in a Regulatory Affairs Department, experience with relevant aspects of Regulatory Affairs activities, Regulatory Agency contact and experience in supervising others
• Familiar with local and EU legislation procedures and guidelines governing medicinal products and medical devices
• Experience in the translation and implementation of product information texts as well as with Market Access strategies
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to internal and external stakeholders
• Fluent in German and English
• Strong project management skills, including the ability to prioritize tasks, manage timelines, and deliver high-quality results under tight timelines
• Meticulous attention to detail, ensuring accuracy in regulatory documentation and compliance with all relevant standards and regulations
• Proficient in working in a modern digital and paperless environment utilizing MS Office tools and collaboration platforms and systems for documentation, analysis, and reporting, enhancing efficiency in regulatory processes
• Client-oriented approach and excellent relationship-building skills

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
People with severe disabilities and their equivalents will be given preference if they are equally qualified.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Description

Brief Description of Position

Position Overview:

Under the direction of the applicable management, the Senior Clinical Data Manager (SCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Primary activities include, but are not limited to:

• All responsibilities of a Clinical Data Manager.
• Assume data management responsibilities for larger, more complex or higher priority protocols.
• May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines, and provide data entry status to the Clinical Development Scientist (CDS).
• Provide protocol specific training of SDE Process to CDM.
• Triage, research, discuss and resolve the reports outputs provided by Clinical Development Scientist (CDS) and Statisticians at a protocol level during in-life and database lock stages supported by the LCDM. Execute special reports in different systems and coordinate the resolution under direction of the LCDM.
• Responsible for the preparation, creation, validation and review of data management tool specifications and tools under the direction of the LCDM, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data Management Plans (DMPs).
• Coordinate User Acceptance Testing (UAT) of the Clinical Database Repository under the direction of the LCDM.
• Coordinates communications, global status tracking and issue resolution at study level with Lead CDM (LCDM).
• Support LCDM in interaction and communication with customers and stakeholders both internal and external to GDMS as well as company when needed.
• Responsible for the communication with Clinical Trial Operations team regarding site level issues on a protocol on behalf of the LCDM.
• Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to LCDM.
• Responsible for study level status assessment, reporting and communication with LCDM.
• Coordinate and mentor CDMs and other SCDMs who work in his/ her protocol to maintain compliance with SOPs, data management plans and data review plans.

• Be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as providing inputs to create or update SOPs, supporting documents and training materials as needed.
• May contribute to special activities such as   supporting DMC Process Owner (PO) Models in the local DMC and/or in the Global PO networks.
• Participate in cross functional technical or process improvement projects.

Qualifications, Skills & Experience

Education:

At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

Knowledge and Skills:

1. Two years’ experience in clinical data management in pharmaceutical or health care clinical research environment is preferable.

2. Self-motivated, excellent in work planning and time management.

3. Fluent oral and written English skills.

4. Good basic awareness of the clinical development process.

5. Good basic awareness of clinical practice and grasp of medical terminology.

6. Good sense and awareness of regulations and policies.

7. Able to work under pressure and in a changing environment with flexibility.

8. Good communication skills with the ability to communicate with both technical and business areas.

9. Proven leadership skills, specifically the ability to coordinate the work of others and influence management on decision making.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

職務概要

クリニカルリサーチマネージャーとしての募集となりますが、入社後数年の経験の後、ご本人のキャリア志向も踏まえて、将来は柔軟に広く社内の様々な部署で活躍していくことも可能となります。

【臨床試験におけるオペレーション業務のリーダー】

米国本社カウンターパートと協力し、試験全般のオペレーション業務における日本国内メンバーのリーダー役を担う

· 試験計画、開始準備、実行、終了に亘り、トライアルチームをリードする

· チームメンバーや各種ベンダーが行う業務が遅滞なく進行するよう取りまとめる

· 試験にかかるコスト、主要マイルストン、リスク等のマネジメントを行う

· CRA（CRO含む）の相談窓口として、施設レベルの課題を解決する

· 試験を通じた文書管理コンプライアンス、各施設におけるクオリティを担保する

資格要件

・TOEIC800点以上、英検準１級など

・海外とコミュニケーションできる英語力

・CRM、Study Manager 等の経験3年以上、または、CROで Project Leader 等の経験3年以上

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Clinical Study Management

Japan Clinical Operations Leader or Sub-Leader

• 治験の計画、開始準備、実行、終了を通じて日本の治験チームを指揮
• 治験のスケジュール管理、コストやリスクなどの管理
• CROメンバーを含むCRAチームの管理
• 全体を通しての品質の確保
• 米国本社の担当者とのコンタクト

必要要件

• 英語力スコア（TOEIC800点以上、英検準1級など）
• グローバルメンバーとコミュニケーションをとるための英語力
• CRM、スタディマネージャー、またはCRO PLとして3年以上の経験

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Position Overview

China Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of assigned program(s) for developing local registration strategy, engaging key opinion leaders, developing study protocol, drafting study report, and preparing dossier for regulatory submission.

Main Responsibility

• This individual will serve as the key interface between headquarter project development team and China development center. The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  
• Whenever Clinical Research designs a clinical study, the clinical research physician (clinical monitor) is expected to drive study design, and collaborate with biostatisticians, regulatory affairs, and other relevant disciplines to construct a high quality clinical study protocol.
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs and investigator meeting during study initiation phase, and review protocol deviation and answer protocol related questions during study implementation phase.
• To develop the best, most suitable clinical plan and protocol, the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair, and marketing and regulatory affair. The clinical physician will be involving in introducing new compounds in development to China scientific leaders and seek feedback for our clinical development plan as needed.
• The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

Requirements

• Master or above degree in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable,
• Be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. 
• have a strong leadership, excellent written and oral communication skills, and project management skills.
• Strong capability of work prioritization and deliver results with parallel multiple tasks.
• Excellent language skills in both English and Chinese (fluent in verbal and written).
• The position may require the flexibility to work outside of the area of primary medical specialization.   

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

For our location in Brussels, we are currently recruiting a:

Health Economics and Outcomes Research Manager

In this role you will help to shape and implement the company’s position in this area in order to capitalize on the opportunities of real-world data and to address potential challenges. Do you have a scientific Master’s or PhD degree and experience in working in the Health Outcomes or Public Health area, performing CE analyses and budget impact models in the pharmaceutical industry or with a CRO company and interested in linking the evidence to discuss with Policy makers? We welcome you to apply for this challenging career opportunity in Brussels.

About the position

The Health Economics and Outcomes Research position is key for the company in order to face the changing health care environment due to the increased pressure by the growing health care expenditures and the choices the payers must make between existing and new interventions. Real-world data have a significant impact on how medicines are developed and evaluated. Their use is increasing and evolving across our health system as payers and clinicians apply these data and linked evidence to decisions about treatment, disease pathways and pricing.

In this role you will help to shape and implement the company’s position in this area in order to capitalize on the opportunities of real-world data and to address potential challenges.

You will be responsible for collecting epidemiological/real life clinical data, designing and implementing economic research studies, building relevant health economics and budget impact models to demonstrate the economic value of the company’s priority products. Important stakeholders will be the national payers in support of the reimbursement files and price negotiations. The other important stakeholders will be the Policy makers where you will be key in creating robust data-based value stories that demonstrate our products represent efficient use of available healthcare funding (create product value propositions (cost-effectiveness)).

You will be in the field for up to 30% of the time and around 5% of the time outside the country.

Welcome to our team

The Market Access division acts as both educators and advocates for the products, processes and practices that help our company revolutionize medicine across the globe. Our tenacious, assertive group of individuals uses a deep understanding of the healthcare market in order to build collaborative relationships with the business leaders, customers, and legislative powers that help cultivate positive uptake of and education about our products throughout the world.

Primary responsibilities

• Identify available data sources (literature, international and national real-life data, local registries …) that support the clinical benefits of the company’s products;

• Define data gaps to support the economic value of our medicines;

• Analyse data, build reports and publish results;

• Design and implement outcomes research & health economic studies that fill these gaps and support key publications, reimbursement strategies along with value dossiers and submissions to various payers (primarily INAMI, and possibly other payers);

• Develop/ write the economic components of class-1 reimbursement submissions to a high quality and in a timely manner;

• Develop/adapt robust data-based models to help deliver tools and messages to support access and policy strategy for Belgium and Luxembourg, and possibly marketing

• Contribute to the development of technical expertise within the group/ company;

You will partner with Internal partners in a cross-functional approach (Market Access, Medical Affairs, Clinical Research, Business, Innovation,…) and external stakeholders (Scientific Societies, Scientific experts, Pharmacists Associations, Sick funds, INAMI/RIZIV, KCE, other policy stakeholders …).

Your profile

• Scientific Master’s or PhD degree, including in Public Health;

• Experience in working in the Health Outcomes area and performing CE analyses and budget impact models in the pharmaceutical industry or with a CRO company;

• Experience with development of Markov models (programming in Excel) and building economic models: Cost-Utility, Cost-Effectiveness and Budget-Impact models;

• Good knowledge of the market access space, preferably in Belgium;

• Knowledge of the Healthcare industry including the pharmaceutical industry (market access, medical, clinical research) is a plus;

• Strong expertise in medical science, epidemiology, clinical trials, pharmacoeconomics including a deep understanding of research methods, health economics, and related disciplines is a plus;

• Experience in public databases and registries is a plus

• Demonstrated ability to undertake complex analyses and to produce clear recommendations and/ or reports;

• Expertise in certain therapeutic areas (i.e. oncology, vaccines) is of high added value;

• Excellent economic and analytical ability and problem solving skills;

• Team worker within the market access and external affairs team, and also able to work cross-functionally on a local and international level;

• Strong oral and written communication skills in English.

• Dutch and French are a plus.           

We offer

We welcome you to a truly global, dynamic and challenging environment with great opportunities for personal development. Our benefits are very competitive and the summary below will give you an idea of what you can expect.

• A competitive salary

• 32 vacation days;

• Meal vouchers;

• Echo cheques;

• Incentive Plan (bonus);

• An excellent pension;

• Free use of gym;

• Travel allowance;

• Different training modules.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):