182 Jobs für Drug Regulatory Manager
Stellenangebote Drug Regulatory Manager Jobs
Job gestern bei StepStone gefunden
Miltenyi Biotec B. V. Co. KG
• Bergisch Gladbach
Homeoffice möglich
[. .. ] T cell product, is currently undergoing pivotal clinical trials on a global scale. Join our highly professional team in bringing new medicines to the market. Job Description [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] As Senior Project Manager, you will support global drug development programs from early development through to worldwide regulatory approval. In this role, you will lead the cross-functional project management effort, ensuring that timelines, interdependencies, and critical deliverables are aligned across all contributing functions. You will serve as the central operational driver to keep the project team coordinated, on track, and focused on achieving key development milestones. Key [. .. ]
Job am 13.09.2025 bei Jobleads gefunden
Medical Director Multiple Sclerosis
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] and/or support cross-functional teams to design and execute clinical development plans from Phase 1 through Phase 2 (proof-of-concept) Coach Clinical Scientists in a line-or functional-
manager status Closely [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] interface with project team leaders as well as safety, clinical pharmacology, clinical operations, biostatistics, regulatory, research and biomarker groups and other members of project teams Lead and/or support internal stakeholder management and governance interactions around project plans and therapeutic area strategy Lead and/or support external engagements with advisory boards, site investigators, health authorities, and other key stakeholders Provide clinical input to programs in [. .. ] a similar field. Board certification and fellowship training or research experience in relevant areas is preferred You bring at least 5 years of experience in longitudinal clinical research, preferably in drug development or clinical trials You hold a strong track record of scientific excellence in the field, evidenced by substantial achievement in designing and implementing clinical trials and/or a high level of scholarship in industry or academia You have experience in clinical drug development within the industry, ideally in the [. .. ]
Job am 10.09.2025 bei Jobleads gefunden
• Basel, Basel- Stadt
Führungs-/ Leitungspositionen
[. .. ] and/or support cross-functional teams to design and execute clinical development plans from Phase 1 through Phase 2 (proof-of-concept) Coach Clinical Scientists in a line-or functional-
manager status Closely [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] interface with project team leaders as well as safety, clinical pharmacology, clinical operations, biostatistics, regulatory, research and biomarker groups and other members of project teams Lead and/or support internal stakeholder management and governance interactions around project plans and therapeutic area strategy Lead and/or support external engagements with advisory boards, site investigators, health authorities, and other key stakeholders Provide clinical input to programs in [. .. ] a similar field. Board certification and fellowship training or research experience in relevant areas is preferred. You bring at least 5 years of experience in longitudinal clinical research, preferably in drug development or clinical trials. You hold a strong track record of scientific excellence in the field, evidenced by substantial achievement in designing and implementing clinical trials and/or a high level of scholarship in industry or academia. You have experience in clinical drug development within the industry, ideally in the [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Translational Executive
• München, Bayern
[. .. ] Bridge preclinical data with clinical study design and execution Provide scientific leadership across translational, biomarker and early development activities Act as a key cross-functional partner to research, [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] clinical and regulatory teams Lead and develop a small, established translational science team (4 members) Experience Ph D or MD in Translational Medicine, Oncology, Pharmacology or related field 10+ years experience in translational sciences within oncology drug development Demonstrated success advancing at least programs from preclinical to IND and Phase I Strong background in solid tumours Experience relevant to radiopharmaceutical or targeted oncology therapies Proven cross-functional leadership in early development settings Comfortable operating both strategically and hands on with scientific data Ideal Profile Senior scientific leader, not just a big company manager Able to guide teams while remaining close to the science Pragmatic, decisive, and data driven Clear communicator with strong stakeholder influence Whats Offered Senior leadership position with meaningful impact on early oncology programs Opportunity to shape translational strategy at a pivotal stage of development Competitive compensation including base salary, bonus [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
• Dortmund, Nordrhein- Westfalen
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience Data [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Experienced CRA Manager
• München, Bayern
[. .. ] the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5, 000 people across 40+ countries. Why Medpace? When you join Medpace, you become part of a team dedicated to supporting the [. .. ] size Companies in 2021 Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation organization, accessibility of staff, open communication, and ensuring timely drug availability Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview. #J-18808-Ljbffr 73157696 [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Medical Affairs Manager
• Essen, Nordrhein- Westfalen
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Medical Affairs Manager
• Düsseldorf, Nordrhein- Westfalen Duesseldorf
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Medical Affairs Manager
• Hamburg
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Neu Job vor 4 Std. bei Jobleads gefunden
Medical Affairs Manager
• Leipzig, Sachsen
Medical Affairs
Manager (m/f/D) Tasks Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO implementation [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job gestern bei Jobleads gefunden
[. .. ] School Diploma or GED (accredited) and four (4) years of relevant work experience. Experience: Two (2) years of relevant work experience (in addition to education requirement) . [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] RCRA and DOT regulatory compliance experience required. OSHA 24-Hour HAZWOPER Certification required. Pre-assignment and/or pre-hire customerspecific drug and/or alcohol testing may be required by certain customercontract requirements. Such testing may include urinalysis, oral swab, drug hair follicle testing and/or alcohol testing. Plans and directs all onsite activities at client location in relation to the storage, transportation and disposal of hazardous and nonhazardous wastes and other [. .. ]
Job gestern bei Jobleads gefunden
Technical Leader Civil Structural Engineering (Remote Eligible, U. S. )
Führungs-/ Leitungspositionen
[. .. ] other nuclear regulator) design certification requirements Establish and maintain technical oversight of the applicable regulations (e. g. , US, other national, or global region) Have other duties [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] as assigned by Manager Interface with internal and external customers, suppliers, partners, licensing, the NRC and international regulatory authorities on technical issues Incorporate design requirements into analyses and design documents Support GE Vernova Hitachi Nuclear Energy (GVH) quality requirements, including participation in design reviews, initiating and Manage the design, analysis, or evaluation of assigned systems using sound engineering principles and adhering to business standards, practices, procedures, and product/ [. .. ] Vernova will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable) . Relocation Assistance Provided: No #LI-Remote-This is a remote position Application Deadline: January 23, 2026 For candidates applying to a U. S. based position, the pay range for this position is between 111, 200.00 and 185, 400.00. The Company pays a geographic [. .. ]
Job gestern bei Jobleads gefunden
• Planegg, Bayern
Purpose of your Job As a Client Project
Manager, you will play a central role in managing client interactions and coordinating with internal teams. Your responsibility is to ensure [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] that drug product development projects progress smoothly, meeting agreed timelines and budgets while maintaining a high level of scientific and strategic insight. You will act as the key link between our clients, the technical teams, and the commercial unit. In this role, you will provide technical guidance to our clients and collaborate [. .. ] track record in clientfacing project management, and a solid understanding of project management methodologies (e. g. , Agile, Waterfall; PMP or PRINCE2 certification is a plus) . Uptodate knowledge of regulatory expectations and quality standards, including ICH guidelines (e. g. , Q5A, Q811, etc. ) , GMP, GLP, and EMA/ FDA requirements relevant to parenteral biopharmaceuticals. Strong communication and organizational skills, with experience in scientific or technical project environments. Fluent English skills (spoken and written) ; German is a plus. Proficiency [. .. ]
Job gestern bei Jobleads gefunden
Biologics CMC Director
• Wien
Führungs-/ Leitungspositionen
[. .. ] leadership for Chemistry, Manufacturing and Controls (CMC) of one or more latestage or commercial biopharmaceuticals with potential upside for the company. You will own the endtoend CMC [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] lifecycle for both Drug Substance and Drug Product, ensuring our manufacturing processes across multiple sites remain at the cutting edge of process technology. In this role, you will lead crossfunctional CMC teams, represent Global Manufacturing Sciences (GMSci) in global product governance forums, and shape the CMC roadmap to support product launches, lifecycle management priorities, [. .. ] or method changes. Be part of global product and governance teams, driving clear decisions on CMC strategy, lifecycle management and technology excellence. Drive preparation and support of CMC content for regulatory submissions (initial filings, market expansions, postmarketing changes, and regulatory commitments) . Act as a subject matter expert in regulatory inspections and audits, ensuring consistent, sciencebased communication of product and process knowledge. Identify and lead implementation of innovation and continuous improvement initiatives process improvements, new technologies, and datadriven approaches to reduce COGs and strengthen supply reliability. Collaborate closely with an assigned CMC Project Manager (who will provide you PM support) . Continuous interaction with Process Product Sciences, Analytical Development, Site Manufacturing Sciences, QA, QC, Engineering, Supply Chain, Validation and Regulatory CMC to ensure aligned, efficient CMC execution across functions and sites. Mentor colleagues and contribute to building CMC expertise and best practices across the [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
• Hamburg
[. .. ] With us, every single employee puts patients first. Make an impact in advancing Cell Therapy by ensuring the highest standards of quality and compliance. We are seeking [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] a Clinical Quality Manager (CQM) (m/f/d) - Cell Therapy to join our Cell Therapy Clinical Operations (CTCO) team. In this role, you will collaborate with the Business Processes, Quality Learning (BPQL) team to provide expert guidance and coaching, enabling the successful delivery of Cell Therapy studies by the Site Management and Monitoring [. .. ] this role, you will provide guidance and advice to Site Management and Monitoring (SMM) teams on applying GCP principles, ensuring their work meets the highest quality standards. You will use regulatory guidance, global standards, and SOPs to offer compliance advice and identify opportunities for improvement. When needed, you will recommend and communicate these improvements to Business Process System Owners (BPOs) . Additionally, you will support SMM management by consulting on compliance learning needs and facilitating training delivery. While overall accountability for [. .. ] experience in clinical operations. Ideally, you have: A Bachelor of Science in a relevant discipline or equivalent professional experience. At least 4 years of operational and/or quality experience in drug development within a pharmaceutical or clinical setting. Solid understanding of business processes, technology, and clinical study information systems. Proven time management skills and the ability to deliver timely responses and support to internal and external stakeholders. Experience working successfully and collaboratively with both internal teams and external partners. Excellent written [. .. ]
Job vor 2 Tagen bei Jobleads gefunden
Medical Affairs Manager
[. .. ] job poster from K-Recruiting Life Sciences We unite the people who make our world healthier by placing top experts with life sciences companies worldwide. Precise. Fast. Accurate. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] Medical Affairs Manager (m/f/D) Tasks : Provide recommendation on Patient-Reported Outcomes (PRO) endpoints, instruments and assessment schedule based upon trial population, comparator and DS strategic objectives Contribute to Patient Experience Data (PED) / PRO-specific aspects of protocol profile, clinical trial protocol and informed consent form development Work with PRO [. .. ] provide Senior Review) Respond to study team queries related to PED Respond to PRO-specific questions received in Requests for Information (RFIs) as part of EU CTR submissions Contribute to regulatory briefing documents as needed Contribute to HTA interactions as needed Consult the HEOR Asset Lead upon request of additional evidence generation to refine the selected PRO strategy for a given trial Review externally-sponsored and real-world study protocols when PED are included Perform the activities described above for ongoing [. .. ] of PROs with key external stakeholders such as FDA, EMA and relevant HTAs Knowledge and experience of Oncology therapy areas is strongly preferred Demonstrates understanding and (advanced) knowledge of key drug development processes, plans, studies, and strategies including any aspects of drug development. Uses knowledge to the organizations advantage; generates new ideas and enables the organization to improve business performance. Demonstrates understanding and (advanced) knowledge of PRO methods and instruments, and the issues and challenges of applying these alongside clinical studies [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
• München, Bayern
Consultant Technology Management
Drug Product Tasks Advise teams for Site-Launch activities for internal and external sites (incl. lab units, SC, RACMC and QA) Communicate with internal and external sites [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] as part of the project Review technical documentation (protocols, reports) associated with manufacturing, tech transfer, site-to-site transfers and PPQ as needed Communicate [. .. ] in the CMC working group meetings and communicate clear, timely and detailed updates on tech transfers and site activities Advice the compilation and technical review of relevant CMC sections of regulatory submissions (MAA) , responses to regulatory questions, briefing books Requirements Ph D (biochemistry, chemistry, pharmacy, engineering or related disciplines) or Masters degree with equivalent professional experience in pharmaceutical sciences preferable Several years of experience in the pharmaceutical industry in a drug development environment Extensive experience in CMC-related functions, including solid [. .. ]
Job vor 3 Tagen bei Jobleads gefunden
Manager (m/f/d) Data Management
• München, Bayern
[. .. ] to-end delivery of data management services for assigned projects/ studies, collaborating with CROs and other vendors to ensure high quality deliverables are on time and within budget [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] to support drug development processes and global submissions. The role partners with internal and external stakeholders to optimize data management technology, processes, and standards. Roles and Responsibilities Establish data management strategy at project/ study level and proactively identify and manage risks for a smaller number of projects/ studies. Plan and direct data management activities for assigned projects/ studies through outsourcing (study startup, conduct, closeout, reporting) . Provide oversight for data management CRO and thirdparty vendors to ensure compliance with GCP, regulatory guidelines, and company SOPs. Ensure data management deliverables meet or exceed expectations regarding quality, time, and cost and that documentation is filed/archived according to applicable requirements. Review and approve clinical study related documents (protocols, data management plan, reports) and lead data review process to ensure data quality. Participate in [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
• München, Bayern
Job Summary Our European activities are growing rapidly, and we are currently seeking a full-time, office-based Clinical Safety
Manager to join our team in Munich. This position plays a [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] key role in the pharmacovigilance process at Medpace, working in a team to accomplish tasks and projects that are instrumental to the companys success. If you want an exciting career where you can use your previous expertise and develop and [. .. ] multiple programs. Experience in writing departmental SOPs and Work Instructions. Experience in PSMF generation and maintenance. Experience in CCDS/ RMP/ Sm PC writing and maintenance. Comprehensive knowledge of global clinical safety regulatory requirements. Excellent verbal and written communication skills. Strong leadership, mentoring, and motivational skills. Exceptional teamwork skills. Ability to work independently. We kindly ask to submit applications in English. Medpace Overview Medpace is a full-service clinical contract research organization (CRO) . We provide Phase I-IV clinical development services to [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
Senior CMC Manager
• München, Bayern
The Senior CMC
Manager will play a key leadership role in defining and delivering CMC strategy across the companys gene therapy pipeline. You will oversee internal and external activities [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] spanning process development, GMP manufacturing, analytical development, and regulatory documentation. This position requires strong technical depth, exceptional cross-functional collaboration, and the ability to drive complex programmes toward clinical milestones. Key Responsibilities Lead the end-to-end CMC strategy for AAV gene therapy programmes from research handover through Phase I/ II clinical studies. Manage CDMOs for both drug substance (AAV vector manufacturing) and drug product (fill-finish) , ensuring adherence to timelines, budgets, and quality expectations. Oversee process development activities, including upstream/downstream optimisation (HEK293 or suspension-based systems) , scale-up, and tech transfer to GMP facilities. Drive analytical method development and qualification, including potency assays, q PCR/ [. .. ]
Job vor 4 Tagen bei Jobleads gefunden
Experienced CRA Manager
[. .. ] the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5, 000 people across 40+ countries. Why Medpace? When you join Medpace, you become part of a team dedicated to supporting the [. .. ] size Companies in 2021 Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation organization, accessibility of staff, open communication, and ensuring timely drug availability Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next: A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview. #J-18808-Ljbffr 72808293 [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Senior Clinical Data Team Lead (Senior DTL) - FSP
• Frankfurt, Hesse
Führungs-/ Leitungspositionen
[. .. ] DTL) - FSP Be among the first 25 applicants. The Sr. CDM will lead and contribute to data management activities in support of Clients studies across all [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] stages of clinical drug development. Summary of Key Responsibilities Contribute to data management activities as a lead study data manager in support of Clients clinical studies. Lead database build activities including leading crossfunctional review of e CRF content, review of edit check specifications, and perform user acceptance testing. Monitor data collection, coding, and cleaning by vendors through tracking of study metrics and targeted data reviews. Oversight of database lock activities and ultimate archiving of study data. Collaborate with internal and external partners, including Biostatistics, Statistical Programming, Clinical Operations, Medical, Quality Assurance, Global Patient Safety and Risk Management, Regulatory Affairs, CROs, central and local laboratories, and other vendors. Establish crossfunctional, internal data review plans, coordinate data cuts/ transfers, and conduct data reviews. Review CRO data management plans, CRF completion guidelines, external data transfer specifications and other study documentation. Contribute to development and implementation of department workflows and infrastructure strategy [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Validation Manager
• Ulm, Baden- Württemberg
Your mission As a Validation
Manager (m/f/d) , you will play a key role in advancing our innovative
drug development program. You will take ownership of all validation [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] activities in the development of our products. Working closely with multidisciplinary teams and external partners, you will ensure our processes and products meet the highest standards of quality, safety, and regulatory compliance. Key responsibilities Reporting to the Senior Director of Quality, the Validation Manager will have responsibility to develop and manage all validation activities under the Quality Management System : Provide expert advice on the validation strategy for development programs. Develop and maintain the Validation Master Plan (VMP) . Develop systems, [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Clinical Oversight Manager (COM) - Germany
Clinical Oversight
Manager (COM) - Germany Join to apply for the Clinical Oversight Manager (COM) - Germany role at kps life The primary responsibility of the (Clinical) Oversight Manager [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] (C) OM) is to ensure adequate Sponsor oversight of the conduct, monitoring and management of one or more clinical studies and assigned monitors at [. .. ] management and monitoring. Ensures high quality conduct and execution of clinical studies at sites according to the protocol and study team and governance requirements in compliance with quality, regional and regulatory (GCP) standards. Addresses issues identified with study conduct, monitoring and site management with Sponsors management, are appropriately communicated/escalated and follows up through resolution. May conduct oversight monitoring visits, co-monitoring visits, monitoring visit report reviews and other Sponsor oversight activities per applicable study plans, as needed. Reviews the submission [. .. ] relevant clinical research (or related) experience. 6+ years experience in monitoring and site management of industry sponsored clinical research (CRA, Clinical Trial Monitor, or equivalent) . Thorough understanding of the drug development and clinical trial process. Ability to assess selected CROs monitoring performance and provide constructive feedback and remediation as necessary. Ability to participate in preparation, conduct and follow up of audits and site inspections. Active management experience of countries and sites in a region. Thorough knowledge of ICH guidelines/ GCP [. .. ]
Job vor 5 Tagen bei Jobleads gefunden
Customer Experience Manager, South Germany Munich, Germany; Nuremberg, Germany; Stuttgart, Germany
• München, Bayern
Customer Experience
Manager, South Germany Level of position: Associate Director Position type: 60 field-based, 40 (home-) office based How will your role help us transform hope into reality? We [...]
MEHR INFOS ZUM STELLENANGEBOT
[...] are looking for a highly motivated and visionary personality who is interested in shaping the treatment of people suffering from a serious [. .. ] AI, IVA Strong commercial business acumen, strategic and innovative thinking Digital and analytical capabilities to analyze, transform data and feedback into insights Adhering to compliance, achieving and maintaining all applicable regulatory, legal and operational rules and procedures Strong communication skills in German English, both written and oral Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism Why Blueprint? At Blueprint Medicines, we achieve impactful results because of our global crew of compassionate innovators the Blue Crew. Through authentic relationships [. .. ] problems, with a focus on allergy/ inflammation and oncology/ hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a track record of success, leveraging our established research, development, and commercial capability and infrastructure, we aim to significantly scale our impact by advancing a broad pipeline of programs ranging from early science to advanced clinical trials in mast cell diseases and [. .. ]
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Häufig gestellte Fragen
Wieviel verdient man als Drug Regulatory Manager pro Jahr?
Als Drug Regulatory Manager verdient man zwischen EUR 60.000,- bis EUR 90.000,- im Jahr.
Wieviele offene Stellenangebote gibt es für Drug Regulatory Manager Jobs bei unserer Jobsuche?
Aktuell gibt es auf JobRobot 182 offene Stellenanzeigen für Drug Regulatory Manager Jobs.
Wieviele Unternehmen suchen nach Bewerbern für Drug Regulatory Manager Jobs?
Aktuell suchen 20 Unternehmen nach Bewerbern für Drug Regulatory Manager Jobs.
Welche Unternehmen suchen nach Bewerbern für Drug Regulatory Manager Stellenangebote?
Aktuell suchen zum Beispiel folgende Unternehmen nach Bewerbern für Drug Regulatory Manager Stellenangebote:
- Cpl Life Sciences (11 Jobs)
- Veeda Lifesciences (11 Jobs)
- wax. (11 Jobs)
- Tubulis GmbH (11 Jobs)
- Pfizer (2 Jobs)
- Denk Pharma GmbH Co. KG (2 Jobs)
In welchen Bundesländern werden die meisten Drug Regulatory Manager Jobs angeboten?
Die meisten Stellenanzeigen für Drug Regulatory Manager Jobs werden derzeit in Bayern (38 Jobs), Nordrhein-Westfalen (25 Jobs) und Baden-Württemberg (17 Jobs) angeboten.
Zu welchem Berufsfeld gehören Drug Regulatory Manager Jobs?
Drug Regulatory Manager Jobs gehören zum Berufsfeld Regulatory Affairs & Management.
