Fsp Clinical Editor
hace 1 semana
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
Bachelor's degree or equivalent and relevant formal academic / vocational qualificationPrevious 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 messageThorough knowledge of medical terminology, statistical concepts, GCP, guidelines ( ICH), and requirements of the FDA and other international regulatory agenciesFamiliarity with interpreting data and excellent analytical abilityEffective oral and written communication skillsGood organizational and planning skillsGood interpersonal skillsAbility to work on own initiativeGood computer literacy and expertiseCompetent word processing skillsSolid understanding of document management systemsSuitable level of expertise within a broad range of medical writing projectsGood knowledge of global and regional medical writing and regulatory affairs duties for clinical trials, marketing authorization and late-phase proceduresCapable of providing general advice and training to othersCapable of working well under pressure and remaining motivatedCapable 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.
We offer an exciting company culture that stands for integrity, intensity, involvement, and innovationOur 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 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...
-
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 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...
-
Clinical Research Physician
hace 1 semana
Barcelona, 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 1 semana
Barcelona, Barcelona, España Subzzeducation A tiempo completoAbout 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...
-
Clinical Research Physician
hace 1 semana
Barcelona, Barcelona, España Subzzeducation 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 Project Manager
hace 1 semana
Barcelona, Barcelona, España Subzzeducation 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 Project Manager
hace 1 semana
Barcelona, Barcelona, España TFS HealthScience A tiempo completoAbout 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...
-
Deputy Editor
hace 1 semana
Barcelona, Barcelona, España RELX A tiempo completoThe Lancet Regional Health - Europe, Deputy EditorDo you enjoy using science to drive change in the world?Are you passionate about improving health outcomes in Europe?About our Team The Lancet Regional Health Europe_ is an OA journal, part of the _Lancet_'s global initiative to advocate for health-care quality and access in all regions of the world. We are...
-
Clinical Trial Associate
hace 1 semana
Barcelona, Barcelona, España TFS HealthScience A tiempo completoRecruiter PLEASE READWe have provided you with a job advert framework to build on, please add the correct business area/line information, as well as the job title, responsibilities and requirements.You should also select the appropriate line for CDS/SGA or SRS as directed below.Please delete this message before advertisingTFS HealthScience is a leading...
-
Associate/manager Clinical Operations
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...
-
Senior Medical Writer
hace 1 semana
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoSenior Medical Writer (EMEA) (FSP; Remote) At Thermo Fisher Scientific, you will 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...
-
Senior Medical Writer
hace 1 semana
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoSenior Medical Writer (EMEA) (FSP; Remote)At Thermo Fisher Scientific, you will 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...
-
Publisher Manager CPA based in Barcelona
hace 1 semana
Barcelona, Barcelona, España International People Solutions B.V. A tiempo completoPublisher Manager CPA based in BarcelonaSolicitar empleo de Publisher Manager CPA based in Barcelona en International People Solutions B.V.Publisher Manager CPA based in BarcelonaSolicitar empleo de Publisher Manager CPA based in Barcelona en International People Solutions B.V. Email Manage/analyse active campaigns to make sure publishers deliver the best...
-
Senior Editor, The Lancet Regional Health
hace 1 semana
Barcelona, Barcelona, España Elsevier A tiempo completoSenior Editor, The Lancet Regional Health Europe page is loaded Senior Editor, The Lancet Regional HealthEurope Apply locations Barcelona London time type Full time posted on Posted 30+ Days Ago job requisition id R73377 Senior Editor, The Lancet Regional Health – Europe Do you enjoy using science to drive change in the world? Are you passionate about...
-
Sso Portfolio Team Lead
hace 1 semana
Barcelona, Barcelona, España Novartis A tiempo completo*Role can be based in Madrid or Barcelona*The SSO Portfolio Team Lead is responsible for the Clinical Project Managers (CPMs), SSO Feasibility Managers and SSO Site Partnership Managers and their study specific activities, including the hiring, training, development, and assignment to ensure adequate and timely portfolio execution. The SSO Portfolio Team...
-
Graduate Statistical SAS Programmer Fsp
hace 1 semana
Barcelona, Barcelona, España Labcorp A tiempo completoOur Flexible Solutions (FSP) department is a well-established, global team within Labcorp Drug Development, with highly skilled and dedicated employees based across APAC, EMEA and the Americas. Our colleagues in FSPx work exclusively for one of our renowned key clients in the pharmaceutical / biotech industry.Our highly successful Biometrics business unit...
-
Intern. Barcelona. Sponsor Dedicated
hace 1 semana
Barcelona, Barcelona, España Syneos Health Clinical A tiempo completoDescriptionInternSyneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their...
-
Medical Writer
hace 1 semana
Barcelona, Barcelona, España Thermo Fisher Scientific A tiempo completoAt Thermo Fisher Scientific, you can find meaningful work that has a positive impact on a global scale. Join our team in bringing our Mission to life - helping our customers create a healthier, cleaner, and safer world. We provide our teams with the resources needed to achieve individual career goals while advancing science through research, development, and...
-
Barcelona, Barcelona, España International People Solutions B.V. A tiempo completoRussian Speaking Publisher Manager based in Barcelona or REMOTESolicitar empleo deRussian Speaking Publisher Manager based in Barcelona or REMOTEenInternational People Solutions B.V.Russian Speaking Publisher Manager based in Barcelona or REMOTESolicitar empleo deRussian Speaking Publisher Manager based in Barcelona or REMOTEenInternational People Solutions...
