The Senior Clinical Trial Manager (Sr. CTM) is a key member of Clinical Operations and will closely partner with the Clinical Program Manager and the EMEA Clinical Trial Manager in the oversight and conduct of the EMEA region. Assists Clinical Program Manager with set-up of regional CRO and other vendors. Oversees and assists the EMEA CTM with the following: day-to-day contact with counterpart at CRO and/or trial site. Leads EMEA regional regulatory submission strategies.
Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Leads or supports cross-functional trial teams, including vendors. Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.
Serve as our EMEA Lead, responsible for launching and growing our consulting presence across Europe. This is a seller-doer leadership role with strong emphasis on business development, client acquisition, and strategic growth. The ideal candidate will bring a portable book of business and may join as an individual or with a team.
Syner-G BioPharma Group is seeking a Regulatory Affairs Consultant to support a global pharmaceutical client in Chemistry, Manufacturing, and Controls (CMC), focusing on post-approval regulatory submissions, providing strategic regulatory guidance and operational support to ensure compliance with FDA, EMA, and global regulatory requirements.
Responsible for implementing and managing the pharmacy’s compliance and regulatory program, ensuring strict adherence to all applicable federal and state laws, regulations, and professional standards. This role is essential in safeguarding the pharmacy’s licensure, operational compliance, and reputation, with particular emphasis on sterile and non-sterile compounding practices.
Veeva is looking for an experienced consultant to lead MedTech Complaints implementations at Veeva’s MedTech customers globally. This role will guide the transformation of our customers’ Complaints Management processes and technology. The MedTech Complaints consultant will work closely with Professional Services teams to ensure delivery success across QMS implementations.
Executes the regulatory strategy for obtaining registration approval of Intuitive's portfolio, according to plan and coordinate with related cross functional teams to compile regulatory documentation for submission to regulatory authorities, maintenance of licenses and change management. Evaluates medical device changes, determines and executes regulatory strategy and ensures compliance. Leads advocacy effort across applicable product regulations, environment management regulations and standards related activities with relevant regulators and Government bodies.
The Healthcare Regulatory and Compliance Specialist (HRCS) II owns the continuous maintenance, accuracy, and strategic growth of MedTrainer’s compliance content library. The role researches federal and state regulations, accreditation standards, and healthcare industry related mandates. Updates or retires library materials; and leverages artificial‑intelligence tools to accelerate discovery and curation of relevant compliance resources.
As the new Global Practice Area Lead for biocides, you will lead and develop the global biocides service proposition within Health Sciences. Work with the Health Sciences Leadership Team and regional teams to develop and implement business strategies in alignment with company goals and key performance indicators. You will grow revenue from new and existing clients, build competencies, use global competencies to enhance work winning, and develop synergies between countries and services, thereby enhancing the Health Sciences biocides market position.
Perform centralized and prompt monitoring activities for Phase I-IV clinical research and/or non-interventional studies (NIS) in accordance with project plans, the protocol, ICH-GCP, and all applicable local and federal regulatory requirements while ensuring patient safety and data integrity using a variety of statistical and analytical tools. Analyze site and study level data in the applicable data analytics tool(s) and may identify risks and trends at the site and study level, as well as operational performance issues.