Medical Science Liaison Associate Stellenangebote


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Stellenangebote Medical Science Liaison Associate Jobs


Job am 07.04.2025 bei Jobleads gefunden

Senior Associate MSL (m/w/d) / Medical Science Liaison (m/w/d) Onkologie, Regionen: Nord, Nordwest

• München, Bayern Career Category Medical Affairs Job Description Als Pionier der Biotechnologie erforscht, entwickelt und produziert Amgen innovative Therapien und ist mit ca. 22.000 Mitarbeitern und Niederlassungen in über 100 Ländern überall auf der Welt präsent. Unsere Arzneimittel helfen Millionen von Patienten bei ihrem Kampf gegen schwere Erkrankungen wie z. B. Krebs, Nieren-oder Herz-/ Kreislauferkrankungen. In Deutschland wird Amgen durch einen Forschungsstandort und einen Vertriebsstandort vertreten. Beide Standorte befinden sich in München. Diese Ausschreibung betrifft den Vertriebsstandort (Amgen GmbH) in der Riesstraße. Senior Associate Medical Science Liaison (m/w/d) / Medical Science Liaison (m/w/d) Onkologie, Regionen: Nord, Nordwest AUFGABENSTELLUNG: Repräsentant:in für die medizinische Abteilung innerhalb der oben genannten Regionen Identifizierung der wissenschaftlichen Experten und Intensivierung bestehender Kontakte Kooperation mit der Abteilung Klinische Forschung bei der Auswahl geeigneter Prüfzentren für klinische Studien und medizinisch-wissenschaftliche Betreuung in deren Verlauf Teilnahme an Studientreffen, nationalen und internationalen Kongressen mit anschließender Berichterstattung über aktuelle Entwicklungen in und Erkenntnissen zu spezifischen Indikationsgebieten Planung und Durchführung medizinisch-wissenschaftlicher Aktivitäten wie Vorträge, regionale Advisory Boards und Fortbildungen Ansprechpartner:in für Investigator Sponsored Studies in der Region Beobachtung des Wettbewerbs im Indikationsgebiet gastrointestinaler Tumore sowie proaktive Zusammenarbeit mit den regionalen funktionsübergreifenden Teams Entwicklung auf die Kundenbedürfnisse zugeschnittener Omnichannel-Ansätze und deren Umsetzung im eigenen Arbeitsbereich VORAUSSETZUNGEN: Abgeschlossenes medizinisches oder naturwissenschaftliches [...]
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Neu Job vor 7 Std. bei Jobleads gefunden Contractor Patient Diagnosis Liaison DACH • München, Bayern [...] For us, this means going where other biopharma companies wont go challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to [...] to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. Position Summary: ultra impact Make a difference for those who need it most The Patient Diagnosis Liaison (PDL) DACH will report to the Associate Medical Director of the DACH (Germany, Switzerland and Austria) Cluster and will mostly be responsible for identifying HCPs (Health Care Professionals) [...]
Job vor 3 Tagen bei Jobleads gefunden

Assistant Clinical Research Associate

Assistant Clinical Research Associate Client: Thermo Fisher Scientific Location: Austria Job Category: Other EU work permit required: Yes Job Reference: 2cca6535a7a0 Job Views: 3 Posted:[...]
MEHR INFOS ZUM STELLENANGEBOTAssistant Clinical Research Associate Client: Thermo Fisher Scientific Location: Austria Job Category: Other EU work permit required: Yes Job Reference: 2cca6535a7a0 Job Views: 3 [...] positive impact on a global scale. Join our colleagues in bringing our Mission to life-enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. Summarized Purpose: Performs remote activities on assigned projects in liaison with the Remote CRA, On-Site CRA and study CTM. Provides support with regards to site preparedness, logistical support to the [...] to Success: Education and Experience: Bachelors degree or equivalent and relevant formal academic/ vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 2 years) . Knowledge, Skills and Abilities: Basic medical/ therapeutic area knowledge and understanding of medical terminology. Ability to attain and maintain a solid understanding of ICH GCP, applicable [...]
Job vor 8 Tagen bei Jobleads gefunden Medical Science Liaison (m (f/d) [...] you passionate about rare diseases and eager to contribute to meaningful innovations in the biotech space? Our client a fast-growing international biopharmaceutical company with European hubs in cities like Munich, Milan, Paris, London, and Madrid is looking for an experienced Associate Medical Advisor who will also serve as Medical Science Liaison (MSL) for Austria. This hybrid role offers a unique opportunity to build scientific partnerships, shape local medical strategies, and work [...]
Job vor 11 Tagen bei Jobleads gefunden

Senior Manager (m/f/x) Medical Affairs QA

• München, Bayern Select how often (in days) to receive an alert: Senior Manager (m/f/x) Medical Affairs QA Date: 26 Mar 2025 Location: All Europe, Europe, 81379 Passion for Innovation. Compassion for Patients. With over 120 [...] people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life. In Oncology, we are driving innovation in solid tumors and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved [...] are in Munich, Germany, and we have affiliates in 15 European countries and Canada. For our Global QA Team we are seeking highly qualified candidates to fill the position Senior Manager (m/f/x) Medical Affairs QA Purpose of the function The Associate Director, Medical Affairs QA will provide leadership and strategic direction for assigned programs, ensuring the successful implementation of the quality [...] for Medical Affairs activities, including interventional studies, non-interventional studies, Compassionate Use Programs, Managed Access Programs, and Investigator-Initiated Studies. This includes the timely escalation of issues, oversight of deviations/ incidents and investigations, management of third-party/ vendor performance, and serving as a liaison to support audits and inspections as needed. Quality Management and Continuous Improvement: Provide leadership and guidance in the development and [...]
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Job vor 13 Tagen bei Jobleads gefunden (Senior) Medical Science Liaison (m/f/x) • Baden- Württemberg Driving Sci Pros strategic client development and commercial strategy across the DACH region for permanent and contract staffing projects. This position is a senior field-based medical expert who will support Medical Affairs aspects such as medical engagement with Key Opinion Leaders (KOL) , disease awareness, and [...] the Head of MSL DACH and will be field-based in the country. A typical week will involve 3-4 days of customer-facing work, with 1-2 days working from home for internal meetings and administration. What will your tasks as (Senior) Medical Science Liaison (m/f/x) be? Create and implement a regional Medical Affairs Plan for the territory aligned with country-specific guidance and priorities. Raise [...] living with serious and rare diseases. Their most valuable resource is their employees, and everything they do is motivated by a patients-first mentality. The company was founded in 1988 in the US and employs over 700 people globally. Seniority level Associate Employment type Full-time Job function Health Care Provider Industries Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr 43216860 [...]
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Job am 06.04.2025 bei Jobleads gefunden

Medical Science Liaison (m/w/d) Rare Diseases-DACH

Medical Science Liaison (m/w/d) Rare Diseases-DACH Join our client in advancing Rare Disease innovation in this job position Proclinical is recruiting for The Medical Science[...]
MEHR INFOS ZUM STELLENANGEBOTMedical Science Liaison (m/w/d) Rare Diseases-DACH Join our client in advancing Rare Disease innovation in this job position Proclinical is recruiting for The Medical Science Liaison (MSL) DACH will report to the Associate Medical Director for the DACH region (Germany, Switzerland, Austria) and will focus on scientific engagement with healthcare professionals (HCPs) involved [...]
Job am 03.04.2025 bei Jobleads gefunden Medical Science Liaison • Frankfurt, Hesse [...] the field of severe infectious diseases and has one groundbreaking innovative new drug for severe infectious diseases in the hospital environment. To help patients get access to this new treatment and to save lives, we are looking for an engaged Medical Science Liaison Manager (m/w/d) with experience as an MSL or as a Sales Representative in Pharma Field Sales who wants to develop [...] Point) . Very good German and English language skills, both written and spoken. Ready to take on this exciting challenge? Apply now to join our clients mission in improving patient lives. We look forward to receiving your application. Seniority level Associate Employment type Full-time Job function Health Care Provider, Science, and Research Industries: Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr 42276226 [...]
Job am 02.04.2025 bei Jobleads gefunden

Medical Science Liaison

• Hamburg, Berlin [...] the field of severe infectious diseases and has one groundbreaking innovative new drug for severe infectious diseases in the hospital environment. To help patients get access to this new treatment and to save lives, we are looking for an engaged Medical Science Liaison Manager (m/w/d) with experience as an MSL or as a Sales Representative in Pharma Field Sales who wants to develop [...] Point) . Very good German and English language skills, both written and spoken. Ready to take on this exciting challenge? Apply now to join our clients mission in improving patient lives. We look forward to receiving your application. Seniority level Associate Employment type Full-time Job function Health Care Provider, Science, and Research Industries Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr 42084502 [...]
Job am 27.03.2025 bei Jobleads gefunden Medical Science Liaison-Hematology (Berlin) Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100 of the qualifications. Sobi encourages you[...]
MEHR INFOS ZUM STELLENANGEBOT[...] compensation for your work Emphasis on work/ life balance Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments Job Description The Medical Science Liaison is responsible for driving country medical activities in alignment with regional initiatives and the Global Medical Plan. This person will proactively manage medical scientific stakeholders and create value for patients through medical and scientific stakeholder engagement, medical scientific projects and scientific communications. This role reports to the Associate Director Medical Science Liaison. Key responsibilities: Identify, develop and maintain collaborative relationships with KOLs, scientific experts and other medical scientific [...]
Job am 23.03.2025 bei Jobleads gefunden

Associate Director Systems Quality Assurance Supplier Material Management

• Frankfurt, Hesse Führungs-/ Leitungspositionen Associate Director Systems Quality Assurance Supplier Material Management Mainz, Germany full time Job ID:8922 As Associate Director Global QA Supplier Qualification Management, you are part[...]
MEHR INFOS ZUM STELLENANGEBOTAssociate Director Systems Quality Assurance Supplier Material Management Mainz, Germany full time Job ID:8922 As Associate Director Global QA Supplier Qualification [...] lifecycle including onboarding evaluation, monitoring such as auditing and performance, and offboarding. Manage internal team members based in US and Germany. Establish excellent working relationships and communicate with compliance/ quality groups, vendors, business partners, and other functions. Act as a liaison to internal BioNTech stakeholders through all phases of the supplier lifecycle. Manage and approve the Approved Supplier List (ASL) and [...] accordingly by your BioNTech-Recruiter. Inspired? Become part of #Team BioNTech. BioNTech, the story At BioNTech, we are more than just a biotechnology company we are a community of innovators, scientists, and leaders dedicated to revolutionizing medicine by translating cutting-edge science into survival. Your contributions here have the potential to improve the health of people worldwide, especially by addressing diseases with high medical needs like cancer and various infectious diseases. Experience a dynamic workplace that embraces diversity in all its forms. We foster [...]
Job am 17.03.2025 bei Jobleads gefunden Associate Director, Quality Assurance-Site Data Leader • Alzey, Rheinland- Pfalz Führungs-/ Leitungspositionen At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis,[...]
MEHR INFOS ZUM STELLENANGEBOT[...] and governance necessary for ongoing data integrity effectiveness. This role will partner with functional area data experts to anticipate and resolve key data management and integrity issues while driving solutions that impact the site and align with corporate objectives. The Associate Director, Quality, will also provide computer system quality assurance oversight during the start-up and routine operation of the Alzey site. [...] system functionality, including but not limited to physical and logical security, Electronic Records/ Electronic Signatures (ER/ ES) , audit trails, data mapping, records/ data backup, archive and retention, computer system validation, infrastructure qualification, investigation, and training programs. Act as site liaison and representative for the data integrity and data management program: Serve as the site liaison with the Global Data Management [...] regulatory inspections. Ensure data integrity by design. Leverage technology to ensure data digitalization and standardization where appropriate. Design, replicate and employ analytics and advanced analytics for competitive advantage within the site. Basic Requirements: Bachelors degree in engineering or computers preferred; Science-related field will be considered. Minimum 5 years working in the pharmaceutical or medical device industry in QA roles. Minimum 3 years of experience in Computer System Quality Assurance/ Computer System Validation. Minimum 3 [...]
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Job am 07.03.2025 bei Jobleads gefunden

Senior Medical Science Liaison

• Niedersachsen Medical Science Liaison (m/f/d) We are looking for an experienced and dynamic Medical Science Liaison (MSL) to join the German team of a [...] advances, this is your opportunity to contribute to cutting-edge research and medical innovation. About the Role The Medical Science Liaison (MSL) will play a key role in building relationships with healthcare providers, thought leaders, and internal teams. Reporting to the Associate/ Medical Director Germany, this role focuses on supporting therapies for rare diseases, with opportunities to contribute to the companys promising [...]
Job am 01.02.2025 bei Jobleads gefunden Medical Science Liaison (Northwest Germany) • Cuxhaven, Stade, Lüneburg, Uelzen, Braunschweig, Niedersachsen [...] compensation for your work Emphasis on work/ life balance Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments Job Description The Medical Science Liaison is responsible for driving country medical activities in alignment with regional initiatives and the Global Medical Plan. This person will proactively manage medical scientific stakeholders and create value for patients through medical and scientific stakeholder engagement, medical scientific projects and scientific communications. This role reports to the Associate Director Medical Science Liaison. Key responsibilities: Identify, develop and maintain collaborative relationships with KOLs, scientific experts and other medical scientific [...]
Job am 27.01.2025 bei Jobleads gefunden

Medical Science Liaison Hematology

[...] compensation for your work Emphasis on work/ life balance Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments Job Description The Medical Science Liaison is responsible for driving country medical activities in alignment with regional initiatives and the Global Medical Plan. This person will proactively manage medical scientific stakeholders and create value for patients through medical and scientific stakeholder engagement, medical scientific projects and scientific communications. This role reports to the Associate Director Medical Science Liaison. Key responsibilities: Identify, develop and maintain collaborative relationships with KOLs, scientific experts and other medical scientific [...]
Job am 26.11.2024 bei Jobleads gefunden Medical Science Liaison Hematology • Köln, Nordrhein- Westfalen Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100 of the qualifications. Sobi encourages you to change[...]
MEHR INFOS ZUM STELLENANGEBOT[...] Competitive compensation for your work Emphasis on work/ life balance Collaborative and team-oriented environment Opportunities for professional growth Diversity and Inclusion Making a positive impact to help ultra-rare disease patients who are in need of life-saving treatments Job Description The Medical Science Liaison is responsible for driving country medical activities in alignment with regional initiatives and the Global Medical Plan. This person will proactively manage medical scientific stakeholders and create value for patients through medical and scientific stakeholder engagement, medical scientific projects and scientific communications. This role reports to the Associate Director Medical Science Liaison. Key responsibilities: Identify, develop and maintain collaborative relationships with KOLs, scientific experts and other medical scientific [...]
Job am 04.04.2025 bei Neuvoo gefunden Proclinical Medical Science Liaison (m/w/d) Rare Diseases-DACH • Munich, Bavaria Healthcare. Join our client in advancing Rare Disease innovation in this job position Proclinical is recruiting for The Medical Science Liaison (MSL) DACH will report to the Associate Medical Director for the DACH region (Germany, Switzerland, Austria) and will focus on scientific engagement with healthcare professionals (HCPs) involved [...]
Job am 07.03.2025 bei Neuvoo gefunden Danaher HR Generalist • Krefeld, North Rhine- Westphalia Human Resources. Wondering whats within Beckman Coulter Diagnostics? Take a closer look. At first glance, youll see that for more than 80 years weve been[...]
MEHR INFOS ZUM STELLENANGEBOTHuman Resources. Wondering whats within Beckman Coulter Diagnostics? Take a closer look. At first glance, youll see that for more than 80 years weve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. Were building a [...] to improve patient lives with diagnostic tools that address the worlds biggest health challenges. The Human Resources Business Partner (HRBP) will focus on developing a partnership with assigned client business functions that facilitates open communication with leadership, advancement of the associate value proposition and educates associates on how they contribute to enterprise-wide goals. This role owns the coordination and implementation of HR processes, policies and programs regarding recruitment, retention, organization development, talent development, associate engagement, on-boarding, succession planning, management training, compensation benefits, HR projects and act as a liaison to payroll. This position is part of the European HR Operations Team located throughout Europe and will be on-site with [...] managing Employee relations matters Language Skills: Fluent in English and German and Dutch a plus Understanding and application of Dutch employment law It would be a plus if you also possess previous experience in: Experience in working in a highly regulated/Medical Device Company Lean and continuous improvement experience such as problem solving tools and or other DBS or lean tools. On [...]
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Job am 07.03.2025 bei Neuvoo gefunden Sobi

Medical Science Liaison/ Sr. Medical Science Liaison

• Bremen Healthcare. Medical Science Liaison/ Sr. Medical Science Liaison Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting [...] ability to communicate in a business environment. Personal attributes You must demonstrate behaviors in line with Sobis core values: Care, Ambition, Urgency, Ownership and Partnership. Location The position is remote covering the area of Hamburg, Bremen and Hannover. Reporting to Associate Director Medical Science Liaison If you are interested in being considered for this role, then please attach an updated copy [...]
Job am 07.03.2025 bei Neuvoo gefunden Sobi Medical Science Liaison/ Sr. Medical Science Liaison • Hamburg Healthcare. Medical Science Liaison/ Sr. Medical Science Liaison Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the[...]
MEHR INFOS ZUM STELLENANGEBOTHealthcare. Medical Science Liaison/ Sr. Medical Science Liaison Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting [...] ability to communicate in a business environment. Personal attributes You must demonstrate behaviors in line with Sobis core values: Care, Ambition, Urgency, Ownership and Partnership. Location The position is remote covering the area of Hamburg, Bremen and Hannover. Reporting to Associate Director Medical Science Liaison If you are interested in being considered for this role, then please attach an updated copy [...]
Job am 07.03.2025 bei Neuvoo gefunden Sobi Medical Science Liaison/ Sr. Medical Science Liaison • Hanover, Lower Saxony Healthcare. Medical Science Liaison/ Sr. Medical Science Liaison Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the[...]
MEHR INFOS ZUM STELLENANGEBOTHealthcare. Medical Science Liaison/ Sr. Medical Science Liaison Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting [...] ability to communicate in a business environment. Personal attributes You must demonstrate behaviors in line with Sobis core values: Care, Ambition, Urgency, Ownership and Partnership. Location The position is remote covering the area of Hamburg, Bremen and Hannover. Reporting to Associate Director Medical Science Liaison If you are interested in being considered for this role, then please attach an updated copy [...]
Job vor 9 Tagen bei NewScientist Jobs gefunden Beth Israel Lahey Health Digital Pathology Coordinator • Boston, Massachusetts, United States, Boston When you join the growing BILH team, you re not just taking a job, you re making a difference in people s lives. The Digital[...]
MEHR INFOS ZUM STELLENANGEBOT[...] trails) f. Organize slides for return to appropriate designated area of the department/ stakeholders 11. Maintain organized spreadsheets and tables for tracking workflow 12. Organized Image Management System according to established methods/ design 13. Problem-solve mechanical issues and maintain equipment (liaison between vendor maintenance/ customer service) 14. Monitor storage/ purge archived files Required Qualifications: 1. Associate s Degree 2. A minimum of one year of work experience in administrative, healthcare or science based field 3. Experience with computer systems required, including web based applications, which may include Outlook, Word and Excel. Competencies: [...] difficult and/or unpredictable situations. Work progress is monitored by supervisor/ manager. Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers. Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers. Knowledge: Ability to demonstrate in-depth knowledge of concepts, practices and policies with the [...]
Job vor 11 Tagen bei NewScientist Jobs gefunden Syneos Health Careers CRA II-Multi Sponsor-Hybrid Working • United Kingdom- Europe- GBR- Home- Based, United Kingdom Description Clinical Research Associate II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical[...]
MEHR INFOS ZUM STELLENANGEBOTDescription Clinical Research Associate II Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the [...] resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities/ communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals/ targets. May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members [...] Additional responsibilities include: o Site support throughout the study lifecycle from site identification through close-out o Knowledge of local requirements for real world late phase study designs o Chart abstraction activities and data collection o Collaboration with Sponsor affiliates, medical science liaisons and local country staff o The SMA II may be requested to train junior staff o Identify and communicate [...]
Job vor 11 Tagen bei NewScientist Jobs gefunden King s College London Research Associate (ENHANCED project) • London, United Kingdom, London (Greater) About us The Institute of Psychiatry, Psychology Neuroscience (IoPPN) is a leading centre for mental health and neuroscience research in Europe. Research from the IoPPN[...]
MEHR INFOS ZUM STELLENANGEBOT[...] the use of reasonable adjustments to reduce healthcare inequalities, and a novel Machine Learning workstream to develop an intervention which may be implemented in routine clinical care. About the role We are looking for a motivated and enthusiastic Post-Doctoral Research Associate who has experience of clinical informatics and using real-world electronic health data. The post-doctoral Research Associate will play key role [...] approvals, data assembly/ analysis specifications, management of large linked datasets, and undertaking/ overseeing statistical analysis with support from other members of the research team. The Research Associate will be a member of the Project Management Group and will help with liaison with multi-disciplinary members of research team across departments and institutions as well as co-ordination to ensure the smooth running of [...] Hours per week) , and you will be offered an fixed term contract until 31/ 03/ 28. About you To be successful in this role, we are looking for candidates to have the following skills and experience: Essential criteria A science or healthcare-related Bachelor s or Master s degree with a healthcare research component (minimum 2:1) PhD in relevant area (awarded or thesis submitted, please provide evidence of this in the document section of the applicatation) High degree of competence in standard medical statistics and in using statistical software packages (e. g. R, Stata or Python) Experience working with large-scale routinely-collected healthcare data [...]
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Job am 03.04.2025 bei NewScientist Jobs gefunden Rhythm Pharmaceuticals Associate Director, Regulatory Affairs • Boston, Massachusetts, United States, Boston Führungs-/ Leitungspositionen Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We[...]
MEHR INFOS ZUM STELLENANGEBOT[...] they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together. Opportunity Overview In the Associate Director, Regulatory Affairs role, you will be responsible for ensuring the development and delivery of science-based, solution-oriented and internally aligned regulatory strategies for the program (s) under your accountability. You will lead the regulatory strategy and [...] relevant regulatory standards and commitments Lead the planning and authoring of content for submissions to Regulatory Agencies (eg, INDs, CTAs, meeting requests, briefing documents, Pediatric Investigation Plans, annual reports) and coordinate responses to Regulatory Agency requests May serve as the liaison between the company and Regulatory Agencies for assigned projects Develop and maintain knowledge of US, EU and ROW regulations as [...] Affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development-both big and small company experience is preferred Demonstrated experience with regulatory programs for products to treat rare diseases and/or unmet medical needs (e. g. , orphan products, fast track, breakthrough therapies, PRIME) Strong FDA and EMA experience required Full functional knowledge [...]
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