FSP Clinical Editor
hace 4 semanas
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 individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Discover Impactful Work:
We are looking for a Senior Document Review Specialist to join our FSP Medical Writing team. This role would be dedicated to one client and fully remote, working from certain EMEA locations. As a Senior Document Review Specialist, you will review documents to ensure quality of a standard that meets or exceeds client's expectations. Documents include: regulatory submissions, integrated clinical study reports, serious adverse event narratives, study protocols and publications. You will be ensuring integrity of data in tables against source documents, instructing others outside of the quality review group on the review process.
A Day in the Life:
• Reviews highly technical documents of all types to ensure a quality standard that meets or exceeds client expectations.
• Ensures scientific logic and clarity of the document by verifying data in tables against source documents, checking for consistency according to current regulatory standards and guidelines.
• Edits for accuracy, consistency, and grammatical correctness
• Adjusts schedule to accommodate unexpected requests for priority review.
• Revises scientific language for usage, flow, clarity, and audience appropriateness.
• Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment.
• Maintains, communicates, and applies knowledge of current guidelines, templates and industry standards.
• Coordinates the work of team members and tracks the status of documents being reviewed.
• Mentors junior team members.
• May represent the department at meetings with clients.
• Contributes to the development and modification of the quality review process.
• Collaborates with the writer to manager alliance account(s)
• Delegates weekly assignments to the quality review team and fields questions as appropriate."
Keys to Success:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’).
Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message
Thorough knowledge of medical terminology, statistical concepts, GCP, guidelines ( ICH), and requirements of the FDA and other international regulatory agencies
Familiarity with interpreting data and excellent analytical ability
Effective oral and written communication skills
Good organizational and planning skills
Good interpersonal skills
Ability to work on own initiative
Good computer literacy and expertise
Competent word processing skills
Solid understanding of document management systems
Suitable level of expertise within a broad range of medical writing projects
Good knowledge of global and regional medical writing and regulatory affairs duties for clinical trials, marketing authorization and late-phase procedures
Capable of providing general advice and training to others
Capable of working well under pressure and remaining motivated
Capable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment"
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
-
Fsp Clinical Editor
hace 1 semana
Barcelona, Barcelona, España 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...
-
Fsp Clinical Editor
hace 1 semana
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoWork ScheduleOtherEnvironmental ConditionsOfficeAt 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...
-
Fsp Clinical Editor
hace 4 semanas
Barcelona, España 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...
-
Sponsor Dedicated Clinical Editor/senior
hace 1 semana
Barcelona, Barcelona, España Syneos Health Clinical A tiempo completoDescriptionSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of everything that we do....
-
Sponsor Dedicated Clinical Editor/senior
hace 2 semanas
Barcelona, España Syneos Health Clinical A tiempo completo**Description** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything...
-
Vp, Head Of Alliance Management, Clinical Fsp
hace 3 días
Barcelona, España Iqvia Argentina A tiempo completo.As VP you will lead the oversight of the strategy and delivery for all large pharma customers and build key strategic customer relationships. Headcount responsibility includes 8 direct reports and 100 indirect.The role will determine strategic goals and objectives as part of the FSP leadership team to ensure operational alignment with senior management...
-
Sponsor Dedicated Senior Medical Editor
hace 1 semana
Barcelona, Barcelona, España Syneos Health Clinical A tiempo completoDescriptionSponsor Dedicated Senior Medical Editor (QC of clinical documents)**Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings...
-
Sponsor Dedicated Senior Medical Editor
hace 3 semanas
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **S**ponsor Dedicated Senior Medical Editor (QC of clinical documents)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical...
-
Sponsor Dedicated Senior Medical Editor
hace 4 semanas
Barcelona, España Syneos Health Clinical A tiempo completo**Description** **S**ponsor Dedicated Senior Medical Editor (QC of clinical documents)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical...
-
Clinical Research Physician
hace 3 días
Barcelona, España Subzzeducation A tiempo completo.About this roleTFS HealthScience is a leading global mid-size 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.As part of our SRS/FSP team, you will be...
-
VP, FSP Clinical Operations
hace 3 semanas
Barcelona, España IQVIA A tiempo completoJob Overview Direct clinical monitoring operations for a broad geographic unit. Develop plans to ensure the allocation of human, material, system and fiscal resources for assigned area of accountability. Determine strategic goals and objectives for designated unit and assures operational alignment with senior management priorities. Lead ownership of...
-
VP, FSP Clinical Operations
hace 4 semanas
Barcelona, España IQVIA A tiempo completoJob Overview Direct clinical monitoring operations for a broad geographic unit. Develop plans to ensure the allocation of human, material, system and fiscal resources for assigned area of accountability. Determine strategic goals and objectives for designated unit and assures operational alignment with senior management priorities. Lead ownership of...
-
Principal Biostatistician, Fsp
hace 3 semanas
Barcelona, España Thermo Fisher Scientific A tiempo completoAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals...
-
Clinical Data Manager
hace 2 semanas
Barcelona, España TFS HealthScience A tiempo completo**Join Our Team as a Clinical Data Manager** **About this role** TFS HealthScience is a leading global mid-size 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)...
-
Clinical Research Associate
hace 3 días
Barcelona, España TFS HealthScience A tiempo completo**Clinical Research Associate (Based in Barcelona) - Regionalized position** **About this role** TFS HealthScience is a leading global, mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing...
-
Sponsor Dedicated Senior Medical Editor
hace 2 meses
Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **S**ponsor Dedicated Senior Medical Editor (QC of clinical documents)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical...
-
Sponsor Dedicated Senior Medical Editor
hace 3 días
Barcelona, España Syneos - Clinical and Corporate - Prod A tiempo completo**Description** **S**ponsor Dedicated Senior Medical Editor (QC of clinical documents)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical...
-
Clinical Research Physician
hace 4 semanas
Barcelona, España Tfs Healthscience A tiempo completoAbout this role TFS HealthScience is a leading global mid-size 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. As part of our SRS/FSP team, you will be...
-
Clinical Research Physician
hace 2 semanas
Barcelona, España TFS HealthScience A tiempo completo**About this role** TFS HealthScience is a leading global mid-size 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. - As part of our SRS/FSP team, you...
-
Clinical Research Physician
hace 3 semanas
Barcelona, España Tfs Healthscience A tiempo completoAbout this role TFS HealthScience is a leading global mid-size 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. As part of our SRS/FSP team, you will be...