Merck Gruppe - MSD Sharp & Dohme

Overview We are a global biopharmaceutical leader committed to enhancing the lives of individuals through a diverse portfolio of prescription medicines, oncology treatments, life-saving vaccines, and animal health products. Our unwavering dedication to delivering innovative solutions is the driving force behind everything we do. Working in a professional and friendly environment, this role provides you with the opportunity to gain practical experience in an IT Automation role and to build a foundation for success in your future. Throughout a twelve-month placement, you will support, develop and improve our IT Automation systems and processes and have opportunities to travel to other sites. You will be part of a friendly, energetic, highly motivated and collaborative team working on supporting the manufacturing operations and system upgrade improvements. This role is based at our Animal Health site in Milton Keynes. Responsibilities Troubleshoot and resolve issues with IT Automation Systems and Digital Solutions Use ServiceNow and Jira to receive, update and resolve operational issues and requests Development and delivery of training packages to business users Implementation of new IT Automation systems in-line with business needs Use business analysis skills for development of new business systems to meet business specifications, project timescales and users' expectations Provide technical expertise to implement and integrate new and existing systems and technologies Opportunity to manage and deliver your own projects with guidance from your mentor Maintain compliance to our company's corporate and regulatory guidelines for IT systems Application of our company's specific System Development Life Cycle to systems Adherence to our company's Standard Operating Procedures (SOPs) in everything you do Ensure that projects follow Cybersecurity, Data Integrity and Good Manufacturing and Lab Practices Eligibility / Education Undergraduate student undertaking an IT Automation & Control, Computing or related area Knowledge of automated systems and technologies such as Human Machine Interfaces (HMIs) and Supervisory Control and Data Acquisition (SCADA) Knowledge of network infrastructure Business Analysis skills (requirements gathering and translating into IT solutions) You must currently be studying at a UK university and will be looking to complete a 12-month student internship as part of your undergraduate degree How to Apply (Please Read): Please complete the online application form by answering questions within the application and upload your CV and Cover Letter in a combined document in the 'resume/CV' section. Our standard Future Talent recruitment process is: An online application, a virtual conversation and then a final assessment. Next Steps In the event of progression to the next stage, a member of our Future Talent team will contact you within two to three weeks of the application closing date. Start Date June 2026 Equal Opportunity Employer We are proud to be a company that embraces diversity and inclusion. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. We encourage colleagues to respectfully challenge each other's thinking and approach problems collectively. For more information visit our Future Talent page! Required Skills Analytical problem solving, Business analysis, Business systems, Clinical research, Communication, Cybersecurity risk management, Data analytics, Database management, Data entry, Data visualization, Document management, Financial analysis, Health economics, Information technology operations, IT automation, Management process, Network infrastructures, Office applications, Process improvements, Project management, Regulatory compliance, Reporting and analysis, Security compliance Preferred Skills Current Employees apply here; Current Contingent Workers apply here Search Firm Representatives Please Read Carefully: Merck & Co., Inc., Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs submitted by search firms without a valid written agreement will be deemed the property of the company. No fee will be paid where a candidate is hired as a result of an agency referral without an existing agreement. Employee Status: Intern/Co-op (Fixed Term) Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Not Applicable Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 10/9/2025 A job posting is effective until 11:59:59 PM on the day before the listed job posting end date. Please ensure you apply no later than the day before the end date. Requisition ID: R367928

Job Description We are a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. Role Profile The Medical Science Liaison - Oncology will have a blend of strong scientific and clinical expertise and a high level of communication skills. You will have the ability to work both independently or as part of a team as the situation demands. A thorough knowledge of the allocated therapeutic and disease area or areas is preferable or the ability to demonstrate the aptitude to rapidly assimilate the knowledge. A comprehensive knowledge of the Association of British Pharmaceutical Industries' Code of Practice to ensure that all activities undertaken are conducted in a non-promotional manner is needed. A working knowledge of the pharmaceutical industry and a thorough understanding of the wider NHS environment is desirable. Excellent Stakeholder relationship skills are needed. This is a field-based role covering territories across the UK and is up to 75% externally focused interacting with Health Care Professionals and other external stakeholders through hybrid ways of working (combination of virtual and face-to-face meetings). The travel will depend on agreed collaboration with HCPs taking into account their needs and preferred ways of working. Key Responsibilities To engage in field-based non-promotional medical and scientific partnership, with the aim of providing high quality, accurate and timely scientific advice to healthcare professionals, providers and other relevant stakeholders regarding the company's products and associated disease area. To identify, develop and maintain credible relationships with healthcare professionals, providers, Scientific Leaders, and academic centres , in the relevant disease area and, in collaboration with relevant internal functions, deliver improved patient outcomes in a given disease area. To contribute to the development and implementation of strategic planning for the UK by providing medical and scientific insight and applying expert knowledge about the product and disease area. Champion cross functional partnership across the business in the delivery of company and team objectives. Maintain integrity and ethical governance for the organisation, always leading by example. Provide fair, balanced, non-promotional and unbiased field-based medical and scientific support in response to specific requests from healthcare professionals. Interacts with healthcare organisations, health professionals, clinical investigators, and other health care providers and organisations in order to provide complete, accurate, balanced, scientifically rigorous, and non-promotional medical and clinical information. Participates in the development of Medical Affairs Plans and implements tactics identified in the Medical Affairs Plans which align with the Company's therapeutic areas of interest and where necessary contribute to advice seeking activities, for example advisory boards. Represents the Medical Department at local or regional non-promotional medical. Identify areas of educational need for the external healthcare community, developing resources and events to address these needs. Facilitates research publication of articles supporting therapeutic areas of interest, in a manner ensuring the independence and objectivity of the publications are maintained. Act as an authoritative resource to all departments for the identification of Scientific Leaders who may collaborate on specific projects or activities. Supports commercial colleagues to provide balanced and scientific information and training, on therapeutic areas related to assigned disease entities. Collaborates with our research laboratories and clinical trials operations personnel to identify potential investigators for clinical development programmes and provide medical and clinical expertise to aid in effective trial engagement in the UK. Completes all planning, organisational and administrative activities necessary to ensure effective and efficient management of geographic territory. Maintain compliance with all statutory requirements and internal procedures for Pharmacovigilance. Ensure that all activities and interactions are conducted in compliance with applicable local, global, and national laws, regulations, guidelines, codes of conduct (including but not limited to the ABPI Code of Practice) company policies and accepted standards of best practice. Demonstrates eagerness to contribute to an environment of belonging, inclusion, equity, and empowerment. Qualifications and Experience: Medical degree, pharmacy degree, or higher science degree preferably a MSc or PhD. Experience in oncology medical affairs is highly preferred, though candidates with MSL experience in another therapeutic area will also be considered High level of knowledge of Association of British Pharmaceutical Industries. Proven relationship building skills with scientific leaders (either in the pharmaceutical industry, healthcare, or academic setting). Possess a comprehensive understanding of how the MSL role can deliver value to both internal and external stakeholders. Understanding of the wider NHS environment and key opportunities for pharmaceuticals and the NHS to partner effectively within the scope of the Association of British Pharmaceutical Industries Code of Practice IT skills, including but not limited to use of Microsoft Office Software Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry professionals ensuring the scientific value of our products is realized. We engage and train internal employees to ensure that they thoroughly comprehend the science behind the medicine and review further unmet medical needs to bolster collaboration and further differentiate our portfolio. Desirable Role Competencies Strategic Thinking: Demonstrates the ability to adapt current work processes to meet emerging needs and changes in job responsibilities. Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation. Demonstrates an understanding of how function's goals and strategy aligns with the broader long-term initiatives. Business & Financial Acumen: Demonstrates understanding of business facts and can use this data when making decisions. Demonstrates working knowledge of our company's core business structure and how own function contributes to and works within the organisation. Demonstrates an understanding of changing industry trends, economic drivers, and their implications for our business. Working Across Boundaries: Demonstrates the ability to act as an intermediary across boundaries. Demonstrates the ability to shift one's mind-set to quickly adapt global strategies for local implementation. Demonstrates the ability to proactively recognise and address potential barriers that may hinder cross-boundary initiatives. Demonstrates skill in developing and maintaining networks. Project Management: Demonstrates the ability to coordinate work tasks with others for timely completion and to avoid potential setbacks. Demonstrates ability to articulate and translate complex needs into clearly thought-out solutions and can effectively deliver on those. Demonstrates the ability to quickly assess limitations of current solutions and can re-design processes and tools so they are user friendly and fit for purpose. 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): Required Skills: Adaptability, Adaptability, Advisory Board Development, Analytical Problem Solving, Analytical Thinking, Animal Vaccination, Clinical Research, Clinical Trial Methodology, Data Analysis, Disease Prevention, ICH GCP Guidelines, Interpersonal Relationships, Medical Affairs, Medical Knowledge, Molecular Oncology, Nephrology, Oncology, Oncology Nursing, Pharmaceutical Industry, Pharmaceutical Management, Pharmaceutical Medical Affairs, Scientific Communications . click apply for full job details

Job Description The Regulatory Affairs team manages a broad portfolio of prescription medicines for the UK largely across the vaccine, oncology, cardiovascular and infectious disease therapeutic areas. A new opportunity has arisen in the UK Regulatory Affairs Department, at the Associate Director level. The individual would manage a team of Regulatory Affairs Specialists, to ensure the smooth operation of all registration activities across the teams defined responsibilities, to enable the company to manufacture and market its products in the UK. In addition to their own defined product portfolio. The role would be responsible for undertaking a variety of regulatory activities across a range of products for the UK market including: Developing regulatory strategy and supporting regulatory filing activities for paediatric submissions, new marketing authorisation (MA) applications and product launches. Maintenance of MAs working via a range of regulatory procedures including submission of variation applications across all aspects of registered particulars. This will include working with the MHRA to support review and obtain approval for changes. Implementation and communication of MA changes across internal stakeholder groups. Ensuring all compliance activities are correctly managed. Generation and maintenance of Product Information, including Summary of Product Characteristics, patient information leaflets and packaging components (including artwork management), which will be in line with regulatory requirements and company approval systems. Developing and maintaining own current awareness of the Regulatory environment of UK and European regulatory legislation, requirements and guidelines to provide advice and expertise internally for matters related to our products. Communicate and review issues and changes within the group to ensure a sound knowledge base within the department. Representation of Regulatory Affairs at cross functional meetings including product acquisitions and ad-hoc product issues, compliance investigations, as required. Utilising and supporting company compliance systems in relation to product responsibilities and meeting compliance expectations. Manage and support non-compliance investigations. Working with Global Regulatory Policy and other stakeholders to advocate for therapeutic areas/local positions on regulatory issues and shape the regulatory environment on selected issues through liaising with trade associations. Management Activities In addition to the above this includes the management of a small team of Regulatory Affairs Specialist direct reports for which responsibilities will include: Setting performance and development objectives towards division's and country's objectives, for each Specialist. Guiding and mentoring them in order to achieve outcomes against the defined priorities. Appraising staff formally at year end and as necessary informally throughout the year. Reviewing and advising on staff training and education needs. Setting and monitoring compliance expectations for direct reports and enabling resolutions where problems are seen. Ensuring regulatory activities are being completed to the required standard across the team through regular contact and support. Assisting and guiding direct report with new projects or regulations to ensure outcome is successful. Deputise where necessary for the Department Head and represent the department as appropriate on regulatory issues. Other Build and maintain sound working relationships with the MHRA. Maintains a positive relationship with internal regulatory contacts. Working as a strong member of the UK regulatory team, contributing to departmental projects and issues. In collaboration with the Department Head, participate in the preparation, processing and training of written procedures to underpin the various regulatory activities as required. Undertake the necessary training prior to performing relevant tasks and ensure on-going compliance with the required processes. Assist in the preparation for PV Inspection and other Audits as relevant and ensure that the regulatory component of these inspections are supported. Qualifications, Skills and Experience Must hold a MS degree in pharmacy or other life science or equivalent. Extensive experience in a Registration Department, dealing with most aspects of registration and experience in supervising others. A sound appreciation of the interactions and relationships of the dept with other groups internally is expected. Must have client-oriented approach and work according to our organization leadership vision. The incumbent must be familiar with local and EU legislation procedures and guidelines governing pharmaceutical products. And have experience working with Health Authorities. Ability to communicate well verbally and in writing is essential, as are good organisational and planning skills. The incumbent should possess a meticulous attention to detail and be flexible enough to successfully handle conflicting time pressures and a large volume of work. A mature and disciplined approach to work is essential as is the ability to coordinate the work of others. The incumbent should be able to demonstrate diplomacy and assertive skills in dealing with internal and external parties. The incumbent must demonstrate proficiency in English language as well as in using the PC for all tasks such as word-processing, spreadsheets, database application, and internet. 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. Closing date for applications: 18/02/2025

Job Description EU Labeling Lead Associate Director General Summary The purpose of Global Labeling is to drive labeling strategy and ensure high quality and compliant labeling documents which ensures the safe and effective use of products for patients and healthcare providers, globally. As part of Global Labeling, and under the supervision of the EU Labeling Group Lead, the EU Labeling Lead Associate Director is responsible for managing the labeling of developmental and marketed products registered under EU procedures (MRP/DCP/CP). This includes collaboration with the cross-functional labeling team to develop and maintain the EU Product Information (including all its Annexes as defined by EU legislation). Responsibilities Manages the updates of the English EU PI (SmPC, Annex II, labeling, package leaflet and other applicable annexes) in collaboration with the Regulatory Affairs Europe team. Ensures that the EU PI adheres to regulatory template/format of EU PI and provides subject matter expertise on associated guidelines and guidance documents including Quality Review of Documents (QRD), in line with industry best practices. Oversees change control for EU labeling documents. Oversees the labeling activities of a team of EU Labeling Lead Senior Specialists. Oversees the monitoring for competitor labeling updates. Ensures the appropriate review and analyses of labeling guidelines and regulations to ensure conformance with EU regulations. Oversees, understands, and interprets complex scientific issues as it relates to regulatory requirements and labeling strategy. Proactively identifies labeling issues. Offers creative solutions and strategies, including risk mitigation strategies. Participates in continuous improvement projects for EU labeling activities and business objectives. Initiates and/or implements procedures, processes, or programs to align with corporate strategies and processes. Ensures adequate support in compliance initiatives. Skills Highly experienced knowledge and understanding of the scientific principles of the drug development process. Specialized knowledge of regulations pertaining to drug product labeling. Experience in Oncology. Good oral and written communication and presentation skills. Process improvement or compliance/quality experience. Good negotiation skills. Ability to develop relationships and work well with others even in demanding situations with a positive attitude. Ability to interact with cross-functional team remotely located. Detail oriented, well organized. High project management skills. Experience in Word, Excel and PowerPoint, and document management tools. Education Bachelor's degree in a scientific or medically related discipline required. Master's degree preferred. Extensive pharmaceutical or relevant experience with a focus on EU regulatory product labeling requirements for marketed and developmental products. 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. Closing date for applications: 16/02/2025 Current Employees apply HERE Current Contingent Workers apply HERE Important Notice 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. Job Posting Details Employee Status: Regular Relocation: Not applicable VISA Sponsorship: Not applicable Travel Requirements: Not specified Flexible Work Arrangements: Remote Shift: Not specified Valid Driving License: Not applicable Hazardous Material(s): Not applicable Job Posting End Date: 02/17/2025 A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID: R333504