Act as Subject Matter Expert for respective Sobi products, experienced in formulation process development for aspetic formulation, ensure reliability and effectiveness of Drug...
The Head of Program Management will have line management responsibility and accountability for Bio R&D program management, maintaining oversight over the innovation portfolio...
The Senior Manager, Medical Writing will collaborate with project teams on the development of clinical pharmacology (main area of focus) and other clinical regulatory documents in...
Obtain a comprehensive working knowledge of our offering and the industry we operate within, maintaining awareness of industry trends, identify and connect with potential new...
The job holder for this role is responsible for managing business relationships with defined stakeholder groups and senior leaders in Development / Clinical Functions for the...
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Responsible for development and maintenance of excellence in Data Assurance, with a focus on operational aspects of individual case safety report (ICSR) and literature global...
Establishment and maintenance of the quality management system according to the pharmaceutical guidelines of Good Distribution Practice; Conducting audits for medical devices and...
The regulatory Affairs Regional manager is responsible for supporting the regulatory activities related to all pharmaceutical products across the EMEA region, including SIP...
The Regulatory Affairs Associate Manager will report to and support the Regulatory Affairs Director/Associate Director by leading the preparation and submissions of regulatory...
Building and shaping the Global Biosimilars & Specialty Care Medical Affairs strategy in close alignment with partner functions and driven by evolving business needs; Informing...
The position provides customer focused leadership in managing and delivering the operational and financial aspects of one or more clinical projects from proposal development to...
As Senior Lead Clinical Data Manager (CDM), you will be responsible for the end-to-end data management process for complex medical research projects in a diverse range of...
As Head of Lab in our Pharmaceutical Development department you can be part of building our innovative project portfolio of Biologicals, starting with assessing developability...
Pharmaceutical Distribution centre require a Supply Chain Manager, supporting the Distribution Centre Senior Manager to lead a team of 24 people in a fast-paced environment....
You identify and implement innovative statistical approaches, you conduct or oversee modelling and simulation activities in support of the clinical trial design, you have acquired...
This role's responsibilities is to manage all aspects of Bio-Rad's EMEA BioPharma selling organization (+15 Headcounts) to achieve top and bottom line growth targets. Carefully...
As (Senior) B&C Manager Germany, you lead the evaluation of customer inquiries (RfP = Request for Proposal) for development, clinical and commercial supply of biopharmaceuticals in...
We are looking for a dedicated Director mRNA research who will enlarge and shape Ethris pipeline of delivery technologies, from early proof of concept to a development candidate....
(S)he will be responsible for the development and execution of the Medical Affairs strategy for Moderna’s Infectious Disease franchise for the countries in the cluster. (S)he...
Plan and manage local regulatory submissions to Swissmedic in compliance with corporate standards and local legal requirements. Maintain existing product registrations (variations,...
Reporting into the Senior Director, DS development, this role will provide scientific and technical leadership for drug substance development projects at various stages of the...
Managing a team of RA Associates that are responsible for compiling and maintaining the CMC part (modules 2 and 3) of medicinal product dossiers for the worldwide registrations of...
Ensure commercial Drug Product batches are manufactured, packed, released and shipped in time. Schedule Drug Product batches and packaging runs with CMO’s, create on monthly...
Would you like to play a role in public health protection and contribute to ensuring the quality of medicines worldwide? Do you have a strong background in analytical chemistry or...
You will provide medical support to ICON project teams on clinical issues to ensure that clinical studies are conducted according to the highest ethical principles and in...
An outstanding and dynamic leader with top communication and people skills, and a deep understanding of health research and innovation, to lead and represent the partnership, a...
As Senior Director & EU QPPV you will provide oversight of adverse events processing, safety data management, the Pharmacovigilance Master File (PSMF), and safety exchange...
Build a continuous and robust pipeline of new Rx+ pre-Business Acceleration Programs (BAP) opportunities through establishing internal ideation processes, capabilities, and...
As Biostatistics Team leader, you will be responsible for providing leadership, guidance, and strategic input as team manager and lead statistician(s) on one or more project...
Coordinate process development activities at C(D)MOs and CROs, and coordinate process transfers within the GMP environment; Coordination and collaboration in the preparation of...
Take the lead in the preparation of documents to support scientific meetings with the authorities. Write, edit, and review of essential regulatory documents in compliance with all...
Work with the appropriate electronic systems soon after a new safety and indication/efficacy information becomes available or the content of the CCDS may change. When approved,...
The Director of Regulatory Affairs-International based in Basel, Switzerland will have the opportunity to lead the regulatory strategy for the assigned projects in collaboration...
Support us in our mission to foster healthy aging by tackling pathogenic senescent cells, become part of a fast-moving, motivated, and high-performing team, committed to quality at...
Take over global responsibility across R&D in leading and steering the field of RNA as a modality within the Drug Discovery process as well as be responsible for coordination of...
Planning and coordination of relevant activities required for medical device conformity assessment under Regulation (EU) 2017/745. Compilation and maintenance of technical...
We are looking for a Pharmacovigilance Manager to join our Pharmacovigilance team where you will manage the day-to-day operations within the Pharmacovigilance (PV) department by...
Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned area. Provides training, consultation and oversees metric...
This position requires excellent interpersonal and matrix leadership skills to support effective partnerships with key internal and external stakeholders including global, regional...
The Head of Global Regulatory Strategy is responsible for providing strategic regulatory leadership to the assigned Sobi portfolio. This includes the development of global...
Define and drive the global Transplant/cGVHD medical strategy in alignment with the overall franchise strategy, develop and drive the implementation of the Global Medical Plan...
As a global function leader, the Head of Regulatory Affairs for Santen CGT leads all aspects of the regulatory strategy for assigned programs in cell & gene therapy. Develop the...
Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more business units/countries....
Reporting to the Clinical Leader, the CRD leads clinical trial strategy of assigned program(s) within clinical development team, including interactions with Clinical Operations,...
Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct...
Leading and coordinating multidisciplinary teams within diagnostic operations, leading and developing a team of four direct reports (Controller & Project Manager)....
Ensuring GCP/GVP quality & compliance oversight Providing strategic direction and leadership to R&D and Medical Affairs Departments under a Quality point of viewDeveloping the...
Provide technical oversight of tech transfer activities; Coordinate local tech transfer activities by running weekly meetings, tracking actions and chasing action owners Track and...
Business Development that encompasses two primary activities, product portfolio selection and product portfolio management. Product portfolio selection is the identification of...
As Group Head Statistical Programming, you will play a key role in providing leadership and strategic inputs for all statistical programming projects within your group (rare...
The Clinical Trial Manager is the Regional or Global Protocol Lead in Regional Clinical Trial Operations (RCTO) responsible for the coordination of clinical operations required to...