Drug Safety Associate Stellenangebote

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Stellenangebote Drug Safety Associate Jobs bei Neuvoo

Job vom 28.11.2024 Jobleads

Associate Medical Director Clinical Science

• Basel- Stadt, Basel, Switzerland Führungs-/ Leitungspositionen

MEHR

Associate Medical Director Clinical Science Full- time Sobi Location: United States Statistics show that women and underrepresented groups tend to apply [...] are in need of life- saving treatments Role Function The Associate Director Clinical Science is responsible for Sobi s clinical development activities and serves as scientific and medical expert on matters relating to the assigned development program including regulatory and drug safety. Key Responsibilities Provide clinical, medical, and strategic input to clinical development plans, while adhering to the highest scientific and ethical [...]

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Stellenangebote Drug Safety Associate Jobs bei Jobleads

Neu Job vor 10 Std. gefunden MSAT Associate Principal Scientist, Bioconjugates Process Expert for Capital Investment Project. . . • Visp, Wallis

MEHR

[...] Conjugates Process Expert . Lonza has a strong track record in the manufacturing of Bio Conjugates from early clinical to large scale commercial supplies. Our dedicated Protein Conjugation Plant facility (PCP) is recognized as a center of excellence for Antibody Drug Conjugates (ADC) as well as other classes of Bio Conjugates. We are experiencing an increased demand in this area and [...] Be responsible for permanent optimization of the project. By positive project evolution, be responsible for the execution of the assigned product/ project in the best possible time, quality, and cost, in compliance with the relevant laws, regulations, and guidelines regarding safety, quality, regulation, hygiene, and the environment from a MSAT point of view. Key Requirements: Master or PhD (preferred) in Bioconjugation, [...]

Job vor 2 Tagen gefunden

Executive Director Clinical Development

• Dortmund, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

[...] for the projects assigned. For example: definition of Target Product Profiles, Asset Evidence Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report/ IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, Release [...] of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within your project in collaboration with the associate Head of Medicine. As an Executive Director Clinical Development, you: You author Investigator s Brochures, Asset Evidence Plans, Core Clinical Trial Protocols and Pediatric Development Plans together with your cross- functional project teams. Mentor a team of Clinical Program Leads. You also provide input to Project Analysis Data Management Plans, Company Core Data Sheet, Annual Safety Report/ IND (Investigational New Drug) Safety Reports. Thanks to your expertise, you provide medical leadership in regulatory meetings and support submission strategy, regulatory dossiers and [...]

Job vor 2 Tagen gefunden VP Clinical Development • Dortmund, Nordrhein- Westfalen

MEHR

[...] for the projects assigned. For example: definition of Target Product Profiles, Asset Evidence Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report/ IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, Release [...] need for studies that need to be conducted and provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within your project in collaboration with the associate Head of Medicine. As a VP Clinical Development, you: Author Investigator s Brochures, Asset Evidence Plans, Core Clinical Trial Protocols and Pediatric Development Plans together with your cross- functional project teams. Mentor a team of Clinical Program Leads. Provide input to Project Analysis Data Management Plans, Company Core Data Sheet, Annual Safety Report/ IND (Investigational New Drug) Safety Reports. Provide medical leadership in regulatory meetings and support submission strategy, regulatory dossiers and safety issues. Maintain an external [...]

Job vor 2 Tagen gefunden

VP Clinical Development

• Leipzig, Sachsen

MEHR

[...] for the projects assigned. For example: definition of Target Product Profiles, Asset Evidence Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report/ IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, Release [...] the need for studies that need to be conducted and provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. You review and approve publications within your project in collaboration with the associate Head of Medicine. As a VP Clinical Development, you: Author Investigator s Brochures, Asset Evidence Plans, Core Clinical Trial Protocols, and Pediatric Development Plans together with your cross- functional project teams. Mentor a team of Clinical Program Leads. Provide input to Project Analysis Data Management Plans, Company Core Data Sheet, Annual Safety Report/ IND (Investigational New Drug) Safety Reports. Provide medical leadership in regulatory meetings and support submission strategy, regulatory dossiers, and safety issues. Maintain an external [...]

Job vor 3 Tagen gefunden Manager/ Associate Director Clinical Pharmacology Lifecycle Management Führungs-/ Leitungspositionen

MEHR

[...] office work. Discover more about our company wide benefits and life at GSK on our webpage Life at GSK GSK Are you energized by a role that requires strategic thinking and extensive internal and external engagement? If so, this Manager/ Associate Director Clinical Pharmacology Lifecycle Management role could be an exciting opportunity to explore. The Manager/ Associate Director Clinical Pharmacology Lifecycle [...] such that adequate expertise and support is provided to business partners and project teams. With appropriate guidance contribute to the design, data analysis, interpretation and reporting of clinical pharmacology studies. With appropriate guidance implement, analyse and report PK, PKPD, and drug- disease modelling and simulation studies. Why you? Basic Qualifications Skills: We are looking for professionals with these required skills to [...] if you do not have them, please still apply: Knowledge of pharmacology, physiology, clinical pharmacology, biopharmaceutics, regulatory affairs, therapeutics and commercialization such that he/ she can assist in managing these interfaces and promote a strong partnership with Medical Affairs, Clinical Safety and other relevant business partners. Experience in the design, analysis, interpretation and reporting of clinical pharmacology studies, including bioequivalence, concentration- [...]
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Job vor 3 Tagen gefunden

Construction Security Manager- Germany

• Wiesbaden, Hessen

MEHR

[...] roots dating back more than 115 years, Conti Federal specializes in military construction, critical infrastructure, secure construction, environmental remediation, and disaster response and recovery. We offer world- class service to our clients while remaining committed to our core values of safety, integrity, and compliance. With offices located worldwide, the Conti Federal team prides itself on its diversity and inclusion and promotes [...] to enhance security measures and respond to incidents. Qualifications For Security Clearance Requirements must be a US Citizen, as required. Has an active DoD Secret Security Clearance. A bachelor s degree plus 3 years of recent specialized experience, OR; An associate s degree plus 7 years of recent specialized experience, OR; A major certification plus 7 years of recent specialized experience, [...] vision on the first day of your employment. Life insurance, 401 (k) matching plan, EAP, wellness programs and many other optional programs are offered as well. All applicants who receive a conditional offer of employment must take a pre- employment drug test and receive a negative result as a condition of hire. Conti Federal is an Equal Opportunity Employer. #J- [...]

Job vor 3 Tagen gefunden Clinical Development Medical Director- Immunology (All levels) • Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

Job Description Summary As our Associate/ Senior Clinical Development Medical Director in our Immunology Development Unit, you will be responsible for the scientific and clinical strategy [...] input for deliverables in the assigned project/ program. Deliverables may include sections of individual protocols consistent with the IDP, data review, program specific standards, clinical components of regulatory documents/ registration dossiers, and publications (e. g. , IBs, Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) . Drive execution of the section of the program in partnership with [...] equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/ scientific area; Clinical practice experience 4 years (including residency) preferred. Fluent oral and written English. Minimum requirement of years of experience in clinical research or drug development will be commensurate with level: Assoc. CDMD 3 years, CDMD 5 years, Snr CDMD 7 years. Working knowledge of [...]

Job vom 29.11.2024

Medical Director Clinical Science

• Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

Associate Medical Director Clinical Science Full- time Sobi Location: United States Statistics show that women and underrepresented groups tend to apply [...] are in need of life- saving treatments Role Function The Associate Director Clinical Science is responsible for Sobi s clinical development activities and serves as scientific and medical expert on matters relating to the assigned development program including regulatory and drug safety. Key Responsibilities Provide clinical, medical, and strategic input to clinical development plans, while adhering to the highest scientific and ethical [...]

Job vom 28.11.2024 Associate Medical Director Clinical Science • Basel, Basel- Stadt Führungs-/ Leitungspositionen

MEHR

Job vom 15.11.2024 VP Clinical Development

MEHR

[...] for the projects assigned. For example: definition of Target Product Profiles, Asset Evidence Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report/ IND Safety Reports, preparation for the Milestones Start of Development, Proof of Clinical Principle, Release of Full Development, Release [...] the need of studies, which need to be conducted, and you provide input to Medical Affairs strategy documents such as Scientific Platform, Publication Plan, Product Maintenance and Optimization Summary. Furthermore, you review and approve publications within your project in collaboration associate Head of Medicine. As a VP Clinical Development, you: You author Investigator s Brochures, Asset Evidence Plans, Core Clinical Trial Protocols and Pediatric Development Plans together with your cross- functional project teams. Mentor team of Clinical Program Leads You also provide input to Project Analysis Data Management Plans, Company Core Data Sheet, Annual Safety Report/ IND (Investigational New Drug) Safety Reports. Thanks to your expertise, you provide medical leadership in regulatory meetings and support submission strategy, regulatory dossiers and [...]

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