Clinical Writing Lead
hace 4 días
Job Description: Senior Medical Writer
About Us:
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 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.
We offer a competitive salary range of $95,000 - $110,000 per year, depending on experience.
Responsibilities:
- Mentors 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 are not limited to:
- 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 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.
About You:
To be considered for this role you should have:
- A bachelor's degree in a life science or related field.
- At least 4-6 years of experience in medical writing including at least 2 years of experience in a lead or supervisory capacity.
- Strong understanding of medical writing principles and regulations.
- Excellent written and verbal communication skills.
- Ability to work effectively in a team environment.
- Familiarity with regulatory requirements and guidelines that affect medical writing including but not limited to ICH-E3 guidelines.
Benefits:
- A competitive salary range of $95,000 - $110,000 per year.
- A comprehensive benefits package including health dental vision and 401(k) matching.
- Ongoing training and development opportunities.
- A dynamic and supportive work environment.
-
Clinical Writing Lead
hace 2 semanas
Madrid, Madrid, España Syneos Health, Inc. A tiempo completoSyneos Health, Inc. is a leading integrated biopharmaceutical solutions organization.We are seeking a Clinical Writing Lead to join our team.About the JobThe Clinical Writing Lead will be responsible for mentoring and leading less experienced medical writers on complex projects.This role will also involve managing medical writing activities associated with...
-
Medical Writing Lead
hace 2 semanas
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completoLead Medical Writer Position OverviewWe are seeking a highly skilled and experienced Lead Medical Writer to join our team at Syneos Health, a leading biopharmaceutical solutions organization. As a Lead Medical Writer, you will play a crucial role in developing and managing medical writing projects, collaborating with cross-functional teams, and ensuring the...
-
Medical Writing Team Lead
hace 4 días
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo**Company Overview**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 that address modern market realities.Our Clinical Development model puts the customer and patient at the center of everything we...
-
Medical Writing Lead Professional
hace 2 semanas
Madrid, Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completoAbout the Opportunity:Syneos Health is a leading fully integrated biopharmaceutical solutions organization that translates unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. As a Medical Writing Lead Professional, you will be responsible for leading writing projects and coordinating medical writing...
-
Medical Writing Team Lead
hace 2 semanas
Madrid, Madrid, España Syneos Health, Inc. A tiempo completoJob SummarySyneos Health, Inc. is seeking a skilled Medical Writing Team Lead to lead and mentor medical writers on complex projects. As a key member of our Clinical Development team, you will contribute to the development of high-quality clinical documents and ensure timely delivery of writing projects.Key Responsibilities- Lead and mentor less experienced...
-
Clinical Writer Team Lead
hace 3 semanas
Madrid, Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completoAbout the RoleWe are seeking an experienced Clinical Writer Team Lead to join our team at Syneos Health.As a key member of our Clinical Development department, you will be responsible for leading medical writing activities and mentoring junior team members.This is an exciting opportunity to work with a dynamic team and contribute to the development of...
-
Clinical Development Medical Writer Lead
hace 2 semanas
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completoCompany OverviewSyneos 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.About UsWe are an agile team driven to accelerate the delivery of therapies because we are passionate...
-
Medical Writing Team Lead
hace 1 semana
Madrid, Madrid, España Syneos Health, Inc. A tiempo completo**About Syneos Health, Inc.**Syneos Health, a leading biopharmaceutical solutions organization, accelerates customer success through unique clinical, medical affairs, and commercial insights.We are driven to simplify and streamline our work to make Syneos Health easier to work with and for. Collaborate with passionate problem solvers to innovate as a team...
-
Lead Medical Writer
hace 4 días
Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completoSyneos Health is a leading provider of integrated biopharmaceutical solutions. Our team is built to accelerate customer success by translating unique clinical, medical affairs, and commercial insights into outcomes.We are continuously looking for ways to simplify and streamline our work to make us easier to work with and for. Our Clinical Development model...
-
Medical Writing Team Lead: Collaborative Expertise
hace 2 semanas
Madrid, Madrid, España Syneos Health, Inc. A tiempo completoJob ResponsibilitiesMentor and lead less experienced medical writers on complex projects as necessary. Act as lead for assigned writing projects. Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Develop or support various documents, including...
-
Senior Medical Writer
hace 3 semanas
Madrid, Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completoJob TitleSr Medical WriterAbout the RoleWe are seeking a highly skilled Senior Medical Writer to join our team at Syneos Health. This is an excellent opportunity for a medical writing professional to take on a leadership role in developing high-quality clinical content for regulatory submissions, clinical trials, and other projects.Key ResponsibilitiesMentor...
-
Clinical Research Lead
hace 2 semanas
Madrid, Madrid, España Ora A tiempo completoAbout OraOra is a leading full-service ophthalmic drug and device development firm, guiding clients across all phases of clinical research to bring new products and therapies to market. With over 45 years of experience, our expert teams have helped earn more than 85 new product approvals.The Role: Lead Clinical Research AssociateAs a Lead Clinical Research...
-
Clinical Research Project Lead
hace 3 semanas
Madrid, Madrid, España Icon Clinical Plc A tiempo completoRole OverviewWe are seeking an experienced Clinical Research Project Lead to join our team in ICON plc, a world-leading healthcare intelligence and clinical research organization.
-
Clinical Documentation Lead
hace 2 semanas
Madrid, Madrid, España Syneos Health, Inc. A tiempo completoAbout the Role:We are seeking a highly skilled Clinical Documentation Lead to join our team. As a Clinical Documentation Lead, you will be responsible for developing and implementing clinical documentation strategies, reviewing and revising clinical documents, and ensuring compliance with regulatory requirements.About Us:Syneos Health, Inc. is a leading...
-
Medical Content Lead
hace 3 semanas
Madrid, Madrid, España Syneos Health, Inc. A tiempo completo**About Syneos Health, Inc.**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...
-
Madrid, Madrid, España Tfs Healthscience A tiempo completoAbout TFS HealthscienceTFS Healthscience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. With over 27 years of experience, we deliver tailored clinical research services in more than 40 countries, focusing on key therapeutic areas...
-
Medical Writing Expert
hace 3 semanas
Madrid, Madrid, España Engineeringuk A tiempo completoAbout the RoleAs a key member of our team at Engineeringuk, we are seeking a skilled Principal Medical Writer to join our team. In this role, you will be responsible for ensuring the highest quality of clinical submission documents, driving the design of these documents, and validating individual study protocol design and clinical study reports.Key...
-
Senior Medical Writing Professional
hace 4 días
Madrid, Madrid, España Syneos Health A tiempo completoSenior Medical Writer Position OverviewSyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into outcomes. Our Clinical Development model puts the customer and patient at the center of our work. We strive to simplify and streamline our...
-
Regulatory Medical Writing Expert
hace 2 semanas
Madrid, Madrid, España Engineeringuk A tiempo completoCompany OverviewAt Engineeringuk, we pride ourselves on being the world's largest and most comprehensive clinical research organisation, driven by healthcare intelligence. Our team is passionate about advancing medical knowledge and improving patient outcomes. SalaryWe offer a competitive salary of $120,000 per annum, reflecting our commitment to attracting...
-
Senior Medical Writing Manager
hace 2 semanas
Madrid, Madrid, España Johnson & Johnson A tiempo completoCompany Overview: Johnson & Johnson Innovative Medicine is a global leader in the development of innovative medical solutions to address important unmet medical needs.Estimated Salary:$123,456 per yearJob Description: We are seeking an experienced Senior Medical Writing Manager to lead our Immunology Regulatory team. As a key member of our Integrated Data...
