Clinical Development Specialist Lead
hace 18 horas
About Our Company
Syneos Health - Clinical and Corporate - Prod is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.
About the Job
In this role, you will be responsible for developing good working relationships with internal and external colleagues, managing medical writing activities associated with individual studies, and coordinating medical writing activities within and across departments with minimal supervision.
You will develop various documents, including clinical study protocols and clinical protocol amendments, clinical study reports, patient narratives, clinical development plans, IND submissions and annual reports, integrated summary reports, NDA and (e)CTD submissions, investigator brochures, clinical journal manuscripts, clinical journal abstracts, and client presentations.
Requirements
- Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
- Extensive knowledge of English grammar with a familiarity with AMA style guide.
- Understanding of FDA and ICH regulations and guidelines strongly preferred.
- Demonstrated effective presentation, proofreading, and interpersonal skills and ensure a team-oriented approach.
- Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
- Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
-
Clinical Development Lead
hace 4 semanas
Barcelona, Barcelona, España Mygwork A tiempo completoLead Clinical DevelopmentThis position provides strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.Key responsibilities include the design, development, and execution of Clinical Development Plans (CDPs), clinical trials, and protocols in accordance with applicable GCP...
-
Clinical Development Lead
hace 4 semanas
Barcelona, Barcelona, España Mygwork A tiempo completoUnlock Meaningful Work at Thermo Fisher ScientificAs a Clinical Development Lead, you will provide strategic leadership and tactical oversight for the clinical/medical aspects of all phases of the clinical drug development process.This role involves designing, developing, and executing Clinical Development Plans (CDPs), clinical trials, and protocols in...
-
Clinical Research Development Associate
hace 3 días
Barcelona, Barcelona, España Worldwide Clinical Trials A tiempo completoWhat We DoWe're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases isn't paved by those who play it safe. It's built by those who take pioneering, creative approaches and implement them with quality and excellence.Our MissionWe work with passion and purpose every day to...
-
Clinical Development Director
hace 4 semanas
Barcelona, Barcelona, España Development Innovations Group A tiempo completoAbout the RoleThis is a key leadership position within the Clinical Development organization, responsible for driving the technology roadmap and delivering toolsets and capabilities to support the organization's goals.The successful candidate will be a business partner accountable for technology roadmap and delivery of toolsets and capability for the...
-
Clinical Operations Specialist
hace 3 días
Barcelona, Barcelona, España Syneos - Clinical And Corporate - Prod A tiempo completoClinical Operations Specialist - Sponsor DedicatedAt Syneos Health, we're seeking a highly skilled Clinical Operations Specialist to join our team in a sponsor dedicated role. As a key member of our Clinical Development model, you'll be responsible for ensuring the highest level of compliance and quality in our clinical trials.Key Responsibilities:Perform...
-
Clinical Trials Specialist
hace 17 horas
Barcelona, Barcelona, España Worldwide Clinical Trials A tiempo completoRole OverviewWe are seeking an experienced Clinical Trials Specialist to join our team at Worldwide Clinical Trials, a leading global contract research organization.About the RoleThe successful candidate will be responsible for overseeing the execution of clinical trials in accordance with regulatory requirements and industry standards.Key...
-
Clinical Development Specialist
hace 2 días
Barcelona, Barcelona, España Tfs Healthscience A tiempo completoTFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.About the Role:We are seeking an experienced Clinical Development...
-
Clinical Development Director
hace 4 semanas
Barcelona, Barcelona, España Development Innovations Group A tiempo completoAbout the RoleThis position will drive the technology roadmap for Clinical Development, focusing on enabling the design and execution of clinical development plans and trials to develop high-value medicines for our patients.Opportunity to shape how technology solutions along the continuum can enable optimal and innovative design of trials.Key...
-
Clinical Development Technology Director
hace 4 semanas
Barcelona, Barcelona, España Development Innovations Group A tiempo completoJob Summary:This role will drive the technology roadmap for Clinical Development, focusing on enabling the design and execution of clinical development plans and trials to develop high-value medicines for our patients.Main Responsibilities:As a Senior Business Partner for Clinical Development, you will be accountable for the technology roadmap and delivery...
-
Clinical Development Technology Director
hace 4 semanas
Barcelona, Barcelona, España Development Innovations Group A tiempo completoJob Summary:As a Clinical Development Technology Director, you will drive the technology roadmap for Clinical Development, focusing on enabling the design and execution of clinical development plans and trials to develop high-value medicines for our patients. You will engage with stakeholders in Clinical Development and across Development verticals to ensure...
-
Clinical Development Team Lead
hace 3 días
Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completoAbout the RoleSyneos Health, Inc. is a leading biopharmaceutical solutions organization that translates clinical, medical affairs, and commercial insights into outcomes to address modern market realities. We are seeking an experienced Clinical Development Team Lead - Medical Writer to join our team in Spain-Europe.The estimated salary for this role is...
-
Clinical Development Technology Director
hace 4 semanas
Barcelona, Barcelona, España Development Innovations Group A tiempo completoJob Summary:This role will drive the technology roadmap for Clinical Development, focusing on enabling the design and execution of clinical development plans and trials to develop high-value medicines for our patients.About the Role:As a key member of the Clinical Development organization, you will be responsible for understanding and identifying...
-
Clinical Development Technology Director
hace 3 semanas
Barcelona, Barcelona, España Development Innovations Group A tiempo completoAbout the RoleThis is a senior business partner role accountable for driving the technology roadmap for Clinical Development, focusing on enabling the design and execution of clinical development plans and trials to develop high value medicines for our patients.As a key member of the Clinical Development Organization, you will engage with stakeholders to...
-
Clinical Development Technology Roadmap Director
hace 4 semanas
Barcelona, Barcelona, España Development Innovations Group A tiempo completoJob SummaryThis role will drive the technology roadmap for Clinical Development, focusing on enabling the design and execution of clinical development plans and trials to develop high-value medicines for our patients.About the RoleAs a Senior Business Partner for Clinical Development IT Solutions, you will be responsible for understanding and identifying...
-
Clinical Operations Specialist
hace 2 semanas
Barcelona, Barcelona, España Syneos - Clinical And Corporate - Prod A tiempo completoJob Summary We are seeking a Clinical Operations Specialist to join our team in Spain. As a Clinical Operations Specialist, you will be responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.Key Responsibilities • Assist Clinical Monitoring staff...
-
Clinical Development Technology Roadmap Director
hace 4 semanas
Barcelona, Barcelona, España Development Innovations Group A tiempo completoJob Summary:This role will drive the technology roadmap for Clinical Development, focusing on enabling the design and execution of clinical development plans and trials to develop high value medicines for our patients.About the Role:As a Senior Business Partner for Clinical Development IT Solutions, you will be responsible for understanding and identifying...
-
Clinical Label Development Specialist
hace 4 semanas
Barcelona, Barcelona, España Mygwork A tiempo completoThis role is with Thermo Fisher Scientific, an inclusive employer and a member of Mygwork – the largest global platform for the LGBTQ+ business community.Please do not contact the recruiter directly.Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description We have a vacancy for a Label Development Specialist in our Global Clinical...
-
Clinical Development Technology Roadmap Director
hace 4 semanas
Barcelona, Barcelona, España Development Innovations Group A tiempo completoJob SummaryThis role will drive the technology roadmap for Clinical Development, focusing on enabling the design and execution of clinical development plans and trials to develop high-value medicines for our patients.About the RoleAs a Senior Business Partner for Clinical Development IT Solutions, you will be accountable for the technology roadmap and...
-
Clinical Development Associate
hace 3 días
Barcelona, Barcelona, España Syneos Health, Inc. A tiempo completoClinical Development AssociateWe are seeking a talented and motivated Clinical Operations Specialist to join our team in Barcelona or Madrid. In this role, you will assist our Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure...
-
Clinical Operations Specialist
hace 2 días
Barcelona, Barcelona, España Syneos - Clinical And Corporate - Prod A tiempo completoJob OverviewAs a Clinical Operations Specialist at Syneos Health, you will be responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. This includes assisting Clinical Monitoring staff with site management activities, serving as a Sponsor...