Senior Executive-clinical Regulatory Writing

**The Career Potential**: Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the...

**Work Schedule** Other **Environmental Conditions** Office We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with...

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...

**Job Description**: Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as...

POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...

**Job Description**: This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Merck/MSD policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, for execution and...

This role is primarily accountable for the end-to-end performance and project management for assigned protocols in compliance with country regulations, policies and procedures, quality standards and adverse event reporting requirements internally and externally. The Senior Clinical Research Manager could be responsible for a particular study for several...

**Job Description**: **Primary Responsibilities**: - Prepares selected components of regulatory clinical documentation - Develops knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects - Participates, with supervision, on document-specific teams - Develops competence in writing, editing, and...

**Job Description**: **Primary Responsibilities**: - Prepares selected components of regulatory clinical documentation - Develops knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects - Participates, with supervision, on document-specific teams - Develops competence in writing, editing, and...

The Associate Medical Writer gains experience writing documents that support the clinical regulatory writing portfolio. With oversight, the Associate Medical Writer: - Prepares selected components of regulatory clinical documents (e.g., clinical study reports, participant narratives, investigator’s brochure updates, informed consents) per company and...

The Associate Medical Writer gains experience writing documents that support the clinical regulatory writing portfolio. With oversight, the Associate Medical Writer: - Prepares selected components of regulatory clinical documents (e.g., clinical study reports, participant narratives, investigator’s brochure updates, informed consents) per company and...

Senior Clinical Research Associate **Category**:Clinical Development**Location**:Bogota, Cundinamarca, CO- **The Position** - The Senior CRA will manage and execute the entire Novo Nordisk clinical trials process in compliance with internal SOPs including GCP-ICH and Colombia regulatory framework.**Activities and Responsibilities** - Clinical Trials...

Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations. With our patients at the center of all that we do, we help to accelerate the development...

This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Head COMs, the person is responsible for execution and oversight of...

**About Us**: **Our Compliance Team** The Compliance Team has a very special role in our mission: support the company's growth by identifying the Compliance risks that Nubank faces in Colombia; designing and implementing controls to protect Nubank from such risks; and by providing advisory to the business units on regulations and internal policies to create...

The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as...

The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country regulations, our company policies and procedures, quality standards and adverse event reporting requirements internally and...

Job Overview Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical...

PPD’s mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams. Our...