Search Results: 133 vacancies
...Description
Regulatory Strategy is seeking to add an Associates to its core team to assist the department with a variety of regulatory analytics and technology deliverables. This dynamic position provides opportunities for working across the firm, including but not...
...Main responsibilities:
Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities including complex Clinical Study Reports...
...Group’s PRA and EBA reports on Capital and RWA including COREP, PRA101, Pillar 2 and Pillar 3 disclosures. Preparation and review of regulatory reporting artifacts comprising of Capital and RWA as per EU and UK regulatory requirements. Manage regulatory change including...
...Job Description
Why join us?
Role purpose
This role is within the Regulatory Reporting teams that require additional support to:
Enhance and improve processes and remediate known issues identified during the BAU process impacting COREP and P3 reporting for...
...Skill required: Clinical Data Operations - Clinical Data Review
Designation: Team Lead/Consultant
Qualifications: BSc/MSc/Bachelor... ..., from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions....
...Management
ABOUT THIS ROLE
Job Purpose :
The Senior Clinical Data Analyst (SCDA) independently performs/lead and/or coordinate... ...Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements. SCDA acts as a subject matter expert on DM...
...enhancing information systems and refining core competencies in R&D, Regulatory, Sustainability & packaging, Medical, and Development, all to... ...with consumers
As the leader of Digital R&D and Clinical Platforms Lead, you will have the responsibility of implementing...
...Job Purpose:
Deliver all clinical audiology services in Amplifon clinics - audiology diagnostics to hearing aid fitting and
verification. Job Specification:
Strong and effective communicator.
Ability to build trust, value others and demonstrate high integrity...
...with key internal stakeholders including HEVA, Medical Affairs, Clinical Development, Commercial and Market Access (2) Constantly... ...operational risk controls in accordance with any and all applicable regulatory standards
Stakeholder: Work closely with Market access,...
...software is tested according to SOPs, lifecycle methodologies and to regulatory requirements.
Testing
Accepts responsibility for... ...and Part 11 validation experience required.
Experience in Clinical Development & Delivery or other similar experience.
Knowledge...
...preparation and presentation in front of Governance Committees, for clinically driven topics relevant to assigned non-core CHC portfolio
~... ...an advantage
Knowledge & Skills:
~Medical/Technical Regulatory writing
~Proficiency in Microsoft office applications (...
...process improvement initiative. Participated in client audit or regulatory inspections. Involved in activities that require interaction... ...Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to...
...and attend audits. Mentors less experienced staff.
• Reviews regulatory/pharmacovigilance publications and information sources to keep... ...for routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee...
...research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of... ...activities through all phases of development and perform regulatory reporting and medical monitoring.
As part of your work with...
...research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of... ...events, case review, follow-up, tracking of reports, and regulatory reporting activities. Optimally collaborates with various parties...
...its competency with a unique blend of functional / domain expertise to serve the technology needs of this industry. we serve Clinical Regulatory and Enterprise domains by providing innovative technology products and automation solutions for companies of various sizes. (...
...focusing on the customer-facing model
Monitor the external environment to stay up to date on the latest therapeutic area research and clinical development, as well as competitor landscape, and summarize and present findings through various communication channels...
...organization's information security roadmap, policies, procedures, and standards which is future-proof and is also in alignment with regulatory requirements and industry best practices.
Conduct regular risk assessments and vulnerability scans to identify potential...
...the medical writing group, including scientific documents and clinical/medical reports; (2) Contribute to overall quality enhancement... ...operational risk controls in accordance with any and all applicable regulatory standards
~ Stakeholder: (1) Work closely with scientific...
...its competency with a unique blend of functional / domain expertise to serve the technology needs of this industry. we serve Clinical Regulatory and Enterprise domains by providing innovative technology products and automation solutions for companies of various sizes. (...