Sr Regulatory Medical Writer
3 semanas atrás
.Sr Regulatory Medical Writer (Home Based - Portugal/Spain/France/Belgium/Germany/Hungary)Updated: January 31, 2025Location: Portugal-Europe - PRT-Home-BasedJob ID:25001445Syneos 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.
We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Job responsibilitiesMentors and leads less experienced medical writers on complex projects, as necessary.Acts as lead for assigned writing projects.Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.Develops or supports a variety of documents that include, but not limited to:- Clinical study protocols and clinical protocol amendments; - Clinical study reports; - Patient narratives; - Clinical development plans; - IND submissionsand annual reports; - Integrated summary reports; - NDA and (e)CTD submissions; - Investigator brochures, as well as; - Clinical journal manuscripts, clinical journal abstracts, and client presentations.Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.Serves as peer reviewer on internal review team providing review comments on draft and final documents.Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.Performs on-line clinical literature searches, as applicable.Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.Completes required administrated tasks within the specified timeframes
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Principal/Sr Regulatory Medical Writer
Há 3 dias
Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiro.Principal/Sr Regulatory Medical Writer (Portugal/Spain/France/Belgium/Germany/Hungary) Updated: March 3, 2025Location: Portugal-Europe - PRT-Home-BasedJob ID: 25001934 Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights...
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Principal/Sr Regulatory Medical Writer
2 semanas atrás
Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiroPrincipal/Sr Regulatory Medical Writer (Portugal/Spain/France/Belgium/Germany/Hungary)Updated: March 3, 2025Location: Portugal-Europe - PRT-Home-BasedJob ID: 25001934Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights...
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Regulatory Medical Writer Team Lead
Há 4 dias
Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiroCompany OverviewSyneos Health, Inc. is a leading biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs, and commercial insights into outcomes.We are built to simplify and streamline our work, making Syneos Health easier to work with and for our employees.Job DescriptionAs a Principal/Sr...
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Regulatory Medical Writer Lead
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Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiro**Job Overview**We are seeking a highly skilled Regulatory Medical Writer Lead to join our team at Syneos Health, Inc. As a key member of our regulatory medical writing department, you will be responsible for mentoring and leading less experienced medical writers on complex projects, acting as lead for assigned writing projects, and managing medical writing...
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Regulatory Medical Writer Lead
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Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiroAbout Syneos HealthSyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique insights into outcomes to address modern market realities. Our Clinical Development model puts the customer and patient at the center of everything we do.We are constantly looking for ways to simplify and streamline...
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Lisboa, Lisboa, Portugal Syneos Health, Inc. Tempo inteiroCareer OpportunitiesSyneos Health offers a dynamic career path for Senior Medical Writers who want to take on leadership roles and make a meaningful impact. As a Regulatory Medical Writer Lead, you will mentor and lead less experienced writers, develop and support complex projects, and drive high-quality deliverables.Our company culture values diversity,...
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