Regulatory Guidelines Stellenangebote

Job gestern bei Jobvector gefunden BioNTech SE

Mathematician as Associate Director (m/f/d)

• Planegg, 82152 Führungs-/ Leitungspositionen Homeoffice möglich [...] Experience in answering health authority questions (FDA, EMA) and in leadings statistics on regulatory submissions, including developing ISE/ ISS packages Good knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus) , regulatory guidelines (ICH, FDA, EMA) Good knowledge of statistical analysis software (SAS or R) and sample size calculation software (e. g. , EAST and/or NQuery) Very good understanding of special topics like Diagnostics, Biomarker, PK/ PD, PRO, RWE, is a plus Very Good analytical skills, ability to analyze complex issues to develop relevant and realistic plans, programs, recommendations, risk mitigation strategies, and the ability to communicate them to cross functional colleagues Strong drive for achieving high quality working results in a timely manner, while always safeguarding ethical standards in work and behaviors Very good communication skills: ability to express complex analysis in clear language an excellent command of English written spokenability to express complex analysis in clear languagean excellent command of English [...]
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Job gestern bei Jobvector gefunden BioNTech SE Mathematician as Director (m/f/d) • Berlin, 12489 Führungs-/ Leitungspositionen Homeoffice möglich [...] (FDA, EMA) and leading in statistics on regulatory submissions, including developing ISE/ ISS packages Experience in leading integrated statistical analyses Excellent knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus) , regulatory guidelines (ICH, FDA, EMA) Excellent knowledge of statistical analysis software (SAS and/or R) and sample size calculation software (e. g. , [...]
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Job am 26.03.2025 bei Jobware gefunden MED- EL Medical Electronics

Technical Writer (m/f/d)

Technical Writer (m/f/d) Research Development Innsbruck, Austria Professionals Full-Time 38.5h Permanent Apply Now Your Tasks Take an active role in creating user documents for cochlear[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] design and localization in accordance with guidelines and standards Edit, structure, manage, and review content for user documentation and user interfaces Support several projects and collaborate with development engineers, UX designers, product managers, and regulatory experts Understand product requirements and regulatory guidelines and respond to stakeholder feedback Contribute to the definition of corporate guides and specifications for technical writing and localization Your [...]
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Job vor 8 Tagen bei StepStone gefunden Coriolis Pharma Research GmbH Facility Manager (f/m/d) Pharma Industry • Martinsried [...] Technical Understanding Repairs: Identify and assess complex technical interdependencies, carry out minor repair and maintenance tasks when needed. Documentation Tracking: Maintain detailed records of routine maintenance work, ad-hoc repairs, and service reports. Safety Compliance: Ensure adherence to health, safety, and regulatory guidelines in all facility-related operations. Risk Management: Detect and mitigate potential risks to prevent downtime and operational disruptions. Contract Management: Oversee [...]

Job am 02.04.2025 bei Mindmatch.ai gefunden Coriolis Pharma Research GmbH

Facility Manager (f/m/d) Pharma Industry

• planegg, BY [...] Technical Understanding Repairs: Identify and assess complex technical interdependencies, carry out minor repair and maintenance tasks when needed. Documentation Tracking: Maintain detailed records of routine maintenance work, ad-hoc repairs, and service reports. Safety Compliance: Ensure adherence to health, safety, and regulatory guidelines in all facility-related operations. Risk Management: Detect and mitigate potential risks to prevent downtime and operational disruptions. Contract Management: Oversee [...]

Job vor 3 Tagen bei JobMESH gefunden MED- EL Technical Writer (m/f/d) • Bavaria [...] design and localization in accordance with guidelines and standards Edit, structure, manage, and review content for user documentation and user interfaces Support several projects and collaborate with development engineers, UX designers, product managers, and regulatory experts Understand product requirements and regulatory guidelines and respond to stakeholder feedback Contribute to the definition of corporate guides and specifications for technical writing and localization Your [...]

Job vor 3 Tagen bei JobMESH gefunden MED- EL Medical Electronics Technical Writer (m/f/d) • Thuringia MED-EL is a leading manufacturer of innovative medical devices for the treatment of various types and degrees of hearing loss. Our unique portfolio of implantable[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] design and localization in accordance with guidelines and standards Edit, structure, manage, and review content for user documentation and user interfaces Support several projects and collaborate with development engineers, UX designers, product managers, and regulatory experts Understand product requirements and regulatory guidelines and respond to stakeholder feedback Contribute to the definition of corporate guides and specifications for technical writing and localization IHRE [...]

Job vor 5 Tagen bei Jobleads gefunden Head of Engineering • Stuttgart, Baden- Württemberg Führungs-/ Leitungspositionen [...] scope of each project from the onset, ensuring that technical and functional requirements are clearly established. Lead the development of the initial engineering concept, translating client requirements into workable engineered designs that align with the architectural vision, budget constraints, and regulatory guidelines. Guide the team in conducting feasibility studies and site assessments to identify potential challenges and opportunities, such as geological, environmental, [...]
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Job am 09.03.2025 bei Jobleads gefunden

Senior Director Biostatistics (Oncology)

Führungs-/ Leitungspositionen [...] (FDA, EMA) and leading in statistics on regulatory submissions, including developing ISE/ ISS packages. Experience in leading integrated statistical analyses. Excellent knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus) , regulatory guidelines (ICH, FDA, EMA) . Excellent knowledge of statistical analysis software (SAS and/or R) and sample size calculation software (e. g. [...]

Job am 08.03.2025 bei Jobleads gefunden Senior Director Biostatistics (Oncology) • Mainz, Rheinland- Pfalz Führungs-/ Leitungspositionen Berlin, Germany; London, United Kingdom; Mainz, Germany; Munich, Germany full time Job ID:8822 Your main responsibilities are: Represent Statistics in all assigned cross-functional clinical study[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] (FDA, EMA) and leading in statistics on regulatory submissions, including developing ISE/ ISS packages Experience in leading integrated statistical analyses Excellent knowledge and experience of clinical development, study designs, advanced statistical methods (adaptive design and/or Bayesian is a Plus) , regulatory guidelines (ICH, FDA, EMA) Excellent knowledge of statistical analysis software (SAS and/or R) and sample size calculation software (e. g. , [...]

Job am 08.02.2025 bei Jobleads gefunden

Germany Manager (m/f/d) Medical Affairs

• München, Bayern Germany Manager (m/f/d) Medical Affairs 1 day ago Be among the first 25 applicants Company Description Santen is a specialized life sciences company with a[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] of ophthalmology products. Leadership and Team Management: Lead and supervise a local Medical Affairs team. Function as Information Officer: Ensure that all internally or externally used information material-both medical and promotional-adhere to German laws (HWG, MPG, AMG) and adhere to regulatory guidelines and industry standards. This includes also approval processes of EMEA projects during their implementation in Germany. Qualifications Education Medical degree [...]
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Neu Job vor 7 Std. bei Jobleads gefunden Information Security Officer, Vice President • Frankfurt, Hesse Führungs-/ Leitungspositionen The VP, Information Security Officer provides cyber risk management oversight for State Street Bank International and sits within the first line of defense. The Information[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] and risk mitigations, while being able to recommend solutions that protect the bank and strengthen our cyber resiliency posture. Having experience aligned to DORA standards and other specific European Regulatory Knowledge that are required within Finance to ensure compliance with regulatory guidelines and standards is critical to the role. Other Key Responsibilities Include: Partner with senior leaders to enable informed risk decisions [...]
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Job gestern bei Jobleads gefunden

Medical Science Liaison Cardiovascular/ Immunology

• Basel, Basel- Stadt [...] ) with experience in a specific Disease Area or with a broad medical background or relevant pharmaceutical experience. Strong Cardiovascular experience required, Immunology desired. Scientific or clinical disease area knowledge, patient treatment trends, clinical landscape. Pharmaceutical industry including compliance and regulatory guidelines. Understanding of science, clinical trial design, and process. Understanding of national and regional healthcare and access environment. Working in a [...]
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Job gestern bei Jobleads gefunden Lab Head (m/f/d) in vitro DMPK • Berlin Jobticket [...] absorption, distribution, and ADME principles. Knowledge of innovative DMPK technologies and their application in drug discovery. Experience working in interdisciplinary teams, with a proven ability to address ADME challenges using in vitro and in vivo PK data. Familiarity with global regulatory guidelines (EMA, FDA, ICH) related to in vitro DMPK and drug-drug interaction evaluation is a plus. Collaborative, self-driven, and proactive mindset, [...]
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Job gestern bei Jobleads gefunden Medical Science Liaison Cardiovascular/ Immunology • Aarau, Aargau [...] with experience in a specific Disease Area or with a broad medical background or relevant pharmaceutical experience. Strong Cardiovascular experience required, Immunology desired : Scientific or clinical disease area knowledge, patient treatment trends, clinical landscape. Pharmaceutical industry including compliance and regulatory guidelines. Understanding of science. Clinical trial design and process. Understanding of national and regional healthcare and access environment. Working in a [...]

Job vor 2 Tagen bei Jobleads gefunden Sr. R Programmer (TEAL Module Development-R/ RShiny) • Köln, Düsseldorf, Dortmund, Nordrhein- Westfalen Updated: April 10, 2025 Location: Germany-Europe-DEU-Home-Based Job ID: 25002129 Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] requirements. Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e. g. ICH) . Maintains well organized, complete, and up-to-date project documentation, testing, and verification/ quality control documents and programs [...]

Job vor 5 Tagen bei Jobleads gefunden

FCO System Engineer ATM Systems (m/w/d)

• Karlsruhe, Baden- Württemberg Work-Life-Balance [...] on Full time Key Tasks Design, develop, and integrate advanced ATM systems, ensuring that all components work seamlessly to meet performance and safety standards. Gather, analyze, and document system requirements, interface specifications, and design protocols, ensuring compliance with industry and regulatory guidelines. Work closely with software, hardware, and operational teams to develop solutions that meet customer needs and maintain overall system reliability. [...]

Job vor 5 Tagen bei Jobleads gefunden SVP, Group Account Director, Switzerland Führungs-/ Leitungspositionen Working at Real Chemistry and in the healthcare industry isnt just a job for us. We got into this field for different reasons, but we[...]

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[...] expand our global footprint outside the US/ UK. In this role you will partner with strategy and creative leads to help establish a global presence in Switzerland. You will play a pivotal role in delivering local insights, cultural nuance, and regulatory guidelines back to our UK-based International Hub for our largest clients, while also being responsible for driving local market growth across [...]
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Job vor 5 Tagen bei Jobleads gefunden

Study Start Up Associate I

• München, Bayern Work-Life-Balance [...] or Designee You are : A high school diploma or local equivalent Bachelors Degree preferably in Life Sciences Minimum of 2 years experience or understanding of clinical study start up requirements and activities Experience of Clinical Trial operations and meeting regulatory guidelines Ability to work independently and also as a team member and to organize tasks, time and priorities, ability to multi-task [...]

Job vor 5 Tagen bei Jobleads gefunden (Sr) Director, Clinical Science Liaison • München, Bayern Führungs-/ Leitungspositionen Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, youll discover meaningful work that makes a positive impact on a global[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] doctoral degree) in a clinical research setting, such as biotech/ pharmaceutical industry, academia, government and/or non-profit. 5+ years of management responsibility. Advanced leadership skills. Expert in navigating scientific literature, interpretation of data and display of data. Knowledge of GCP/ IHC, regulatory guidelines and precedents. Excellent interpersonal and communication skills. Strong attention to detail. Good interpersonal skills, prioritization and time management skills. Ability [...]

Job vor 7 Tagen bei Jobleads gefunden Senior Manager-Governance, Change and Transformation Senior Manager-Governance, Change and Transformation Take hold of a monster opportunity and join our Finance and Tax team as a Senior Manager-Governance, Change and Transformation.[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] practices. Reporting to the General Manager-Finance and Tax, you will ensure that policies are designed and maintained, change is managed across the business area, process excellence is assessed, and finance processes are in line with tax and accounting standards and regulatory guidelines. You will also be responsible for continuous improvement and the formulation of associated policies and practices, strategic change, while developing [...]
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Job vor 7 Tagen bei Jobleads gefunden Director (all genders) Translational Research Lead, RU Neuroscience Immunology • Biebesheim am Rhein, Hessen Führungs-/ Leitungspositionen Your role: In this pivotal role, you will bridge nonclinical research and clinical development, facilitating the translation of scientific discoveries into innovative therapeutic solutions. You[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] PhD in Neuroscience or neuro-immunology, with a minimum of 12 years of industry experience. You have proven experience in early and translational research within the pharmaceutical or biotechnology industry. You possess a strong understanding of nonclinical and clinical trial processes, regulatory guidelines, and drug development. You have experience writing nonclinical sections for regulatory documents. You are skilled in collaborating and managing external [...]

Job vor 7 Tagen bei Jobleads gefunden Director (Technology Operations) Führungs-/ Leitungspositionen The role of the Director (Technology Operations) is to provide operational leadership in service delivery technology, service management and improve operational efficiency to ensure reliable[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] ensuring high availability and reliability. Establish protocols for rapid response to system failures and security breaches, and provide leadership for the business continuity and disaster recovery of technology platforms by implementing a business recovery strategy. Ensure adherence to legal and regulatory guidelines, security policies and develop risk mitigation strategies. Stay abreast of emerging technologies and trends, evaluating and implementing tools that enhance [...]

Job vor 8 Tagen bei Jobleads gefunden Senior Manager, Global Labeling Product Leader • Allschwil, Basel- Landschaft Führungs-/ Leitungspositionen At Johnson Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated,[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] Relevant experience in the pharmaceutical industry (e. g. , Regulatory Affairs, Clinical, Medical Information, Pharmacovigilance, etc. ) is required. An understanding of pharmaceutical drug development is required. Experience in discussing and communicating scientific concepts is required. Good understanding of worldwide regulatory guidelines and their applications for guidance for labeling is required. Experience leading project teams in a matrix environment is required. Experience [...]
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Job vor 8 Tagen bei Jobleads gefunden In Vivo Pharmacologist • Basel, Basel- Stadt Key Responsibilities: In Vivo Studies: Plan, design, and execute in vivo pharmacology experiments using animal models to evaluate the effects of drug candidates on physiological[...]

MEHR INFOS ZUM STELLENANGEBOT

[...] studies. Data Analysis and Reporting: Analyze data from in vivo studies, prepare detailed reports, and communicate findings effectively with multidisciplinary teams. Present results to internal and external stakeholders. Regulatory Compliance: Ensure all in vivo studies are conducted in compliance with regulatory guidelines (e. g. , GLP, ICH, FDA) and ethical standards, including proper animal welfare practices. Collaboration: Work closely with other departments, [...]