Clinical Trial Reg Affairs Specialist Ii
hace 1 mes
**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
The following skills are required to be successful in this position:
- preparation and assembly of global regulatory submissions
- interacting with sponsors,
- review and assess clinical trial regulatory documents,
- review and assess scientific literature.
- manages project teams and preparation
- participate in launch meetings, review meetings and project team meetings.
Optional skills:
- Experience with bid defense meetings
**Qualifications - External**
What the role requires you to have:
- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Knowledge of the global clinical trials landscape
Knowledge, Skills and Abilities:
- Excellent command of the English language (written and oral) as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
- Excllent analytical, investigative and problem-solving skills
-
Reg Affairs Specialist
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office We are currently seeking a 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...
-
Sr Reg Affairs Spec
hace 3 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **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...
-
Sr Reg Affairs Spec
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...
-
Sr Reg Affairs Spec
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office In this role you will be a pivotal team member with regulatory affairs responsibilities, leading discussions, and coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects. You will be part of a global team providing innovative...
-
Clinical Trial Assistance
hace 6 meses
Desde casa, México IQVIA A tiempo completo**Global Clinical Trials Assistant - Home Based role** Location: México City / Monterrey **Services Overview**: Clinical Trial Assistance services provides global support for the Local Trial Manager (LTM)/Trial Manager (TM) and/or Site Manager (SM) or Bus ops CTL&D. **Deliverables**: - Services rendered will adhere to applicable Johnson & Johnson SOPs,...
-
Fsp Clinical Trial Coordinator
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Job Purpose**: - Clinical Trial Coordinator - Project Specialist is a key member of the Global Study Team contributing to delivering the clinical study to time, cost and quality, and ensuring inspection readiness by taking an oversight over study eTMF completeness. - CTC role was...
-
Trial Patient Payment Associate Ii
hace 4 días
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **Trial Patient Payment Associate II**: Join Thermo Fisher Scientific Inc. for an outstanding opportunity as a Trial Patient Payment Associate II. Work alongside a skilled team to manage payment processes for clinical trial patients. This role is ideal for ambitious individuals...
-
Clinical Trial Manager
hace 3 meses
Desde casa, México ICON A tiempo completoWe are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials, ensuring adherence to timelines, budgets, and regulatory guidelines. As a leader in our research department, you will...
-
Regulatory Affairs Specialist
hace 8 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Summarized Purpose**: Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local,...
-
Clinical Trial Coordinator Ii
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD —locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving therapies to patients. Our...
-
Clinical Trial Coordinator Ii
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD —locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving therapies to patients. Our...
-
Clinical Trial Coordinator Ii
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD —locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving therapies to patients. Our...
-
Clinical Trial Coordinator Ii
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoWe are vital links between an idea for a new medicine and the people who need it. We are the people of PPD —locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering lifesaving therapies to patients. Our...
-
Fsp Clinical Trial Coordinator Ii
hace 1 mes
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed...
-
Fsp Clinical Trial Coordinator Ii
hace 3 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Other **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...
-
Sr Reg Affairs Spec
hace 2 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office In this role as a Sr Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory...
-
Clinical Trial Reg Affairs Specialist Ii
hace 7 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoAct as an administrator for our in-house Regulatory Intelligence database and provide customer support for issues arising. - Regulatory collaboration with Regulatory Intelligence database workflow users to drive quarterly EQR metrics. - Contribute to a wide range of technical Regulatory Intelligence database content projects including engineering and...
-
Clinical Trial Manager
hace 6 meses
Desde casa, México ICON A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
-
Clinical Trial Coordinator
hace 3 meses
Desde casa, México Thermo Fisher Scientific A tiempo completo**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **CTC-L** We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative...
-
Clinical Trial Coordinator
hace 6 meses
Desde casa, México Thermo Fisher Scientific A tiempo completoCTC-L **Job Description**: We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost...