- Protocols and
- Clinical Study Reports (CSRs)
- Lead Kick-off strategy meetings, to align geographically distributed teams, setting goals, milestones, and critical path forward.
- Conduct Communication strategy meetings, to consolidate contributions from experts to produce a cohesive Shell Skeleton Report.
- Facilitate Comment resolution meetings, to manage conflicting comments early and ensuring smooth protocol development.
- Maintain alignment with sponsor goals, project status and milestones across all teams.
- Foster regular communication with functional leads/reviewers to streamline document development (getting inputs timely, consolidating contributions, answering questions.)
- Critically interpret raw study data (efficacy, exposure, end-point, safety, etc.) into clear concise language in Protocols and CSRs.
- Advanced degree in life-sciences (PhD or Masters)
- Minimum 4 years of regulatory medical writing experience, including at least 2 years as medical writing project lead .
- Extensive experience and proficiency in writing and leading development of CSRs and Protocols .
- You will leverage your experience to manage writing projects, coordinate and collaborate with stakeholders, steer discussion, drive consensus and facilitate decision-making to propel the document development cycle forward.
- You must be comfortable leading team discussions, managing complex medical writing tasks and processes, engaging with a variety of stakeholders, and confidently contributing your expertise based on experience.
- Are you prepared to assume augmented responsibilities and adaptability across environments and therapeutic areas?
-
Senior Cra-sponsor Dedicated-global Cro
hace 2 días
NonStop Consulting Madrid, EspañaEstoy trabajando con una de las mejores CRO a nível mundial para buscar a un Senior CRA sponsor dedicated para alguno de sus nuevs sponsors. Hay muchas oportunidades de promocion interna ya que los managers siempre estan intentando promocionar a los empleados, ademas cualquiera q ...
-
Cra I Madrid. Sponsor Dedicated
hace 2 días
Syneos Health Clinical Madrid, España**Description** · **Clinical Research Associate I** · 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 m ...
-
Cra I. Madrid. Sponsor Dedicated
hace 4 días
Syneos Health Clinical Madrid, España**Description** · **Clinical Research Associate II** · Syneos 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- ...
-
Sponsor Dedicated Clinical Editor/senior
hace 4 días
Syneos Health Clinical Madrid, España**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 Deve ...
-
Sponsor Dedicated Senior Medical Editor
hace 1 semana
Syneos Health Clinical Madrid, España**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 ins ...
-
Cra Ii North of Spain. Sponsor Dedicated
hace 4 días
Syneos Health Clinical Madrid, España**Description** · **Clinical Research Associate II** · 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 ...
-
Clinical Trial Supplies Manager, Sponsor Dedicated
hace 1 semana
Syneos Health Clinical Madrid, España**Description** · **Clinical Trial Supplies Manager** · 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 ...
-
Ssu Local Lead. Madrid. Sponsor Dedicated
hace 2 días
Syneos - Clinical and Corporate - Prod Madrid, España**Description** · **Site Start-Up Project Delivery Lead** · 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 mo ...
-
Sponsor Dedicated Clinical Trial Manager Ii/ Sr
hace 1 semana
Syneos Health Clinical Madrid, España**Description** · **Sponsor dedicated Clinical Trial Manager II/ Sr CTM - Home Based in Spain** · Experience in the management of **global/multi-country** studies and different types of vendors is required. · Syneos Health is the only fully integrated biopharmaceutical solutions ...
-
Sr Cra I. Madrid or Barcelona. Sponsor Dedicated
hace 4 días
Syneos Health Clinical Madrid, España**Description** · **Senior Clinical Research Associate I** · 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 m ...
-
Mgr, Clin Ops Spain. Sponsor Dedicated. Previous
hace 1 semana
Syneos Health Clinical Madrid, España**Description** · **Manager, Clinical Operations** · Syneos 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-va ...
-
Syneos Health Clinical Madrid, España**Description** · **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based - Spain/Italy/Portugal** · Experience in the management of **global/multi-country** studies and different types of vendors is required. · Syneos Health is the only fully integrated biopharmaceuti ...
-
Syneos Health Clinical Madrid, España**Description** · **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN** · Experience in the management of global/multi-country studies and different types of vendors is required. · Syneos Health is a leading fully integrated biopharmaceutical solutions org ...
-
Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm
hace 1 semana
Syneos Health Clinical Madrid, España**Description** · **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based Spain** · Experience as CTM on international or multi country studies is preferred · Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerat ...
-
Sponsor Dedicated Clinical Trial Manager Ii/ Sr Ctm
hace 1 semana
Syneos Health Clinical Madrid, España**Description** · **Sponsor Dedicated Clinical Trial Manager II/ Sr CTM - Home Based in SPAIN** · Experience in the management of global/multi-country studies and different types of vendors is required. · Syneos Health is a leading fully integrated biopharmaceutical solutions org ...
-
Clinical Research Associate- Sponsor Dedicated
hace 2 días
IQVIA LLC EspañaClinical Research Associate- Sponsor Dedicated page is loaded · Clinical Research Associate- Sponsor Dedicated · Apply locations Madrid, Spain Barcelona, Spain time type Full time posted on Posted Yesterday job requisition id R Clinical Research Associate · IQVIA Spain is lo ...
-
Clinical Research Associate- Sponsor Dedicated
hace 1 semana
Iqvia Argentina Madrid, EspañaClinical Research Associate IQVIA Spain is looking for talented and motivated team member to join our Sponsor dedicated team as junior CRA. At this position you will have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide ...
-
Clinical Research Associate- Sponsor Dedicated
hace 5 días
Iqvia Madrid, EspañaClinical Research AssociateIQVIA Spain is looking for talented and motivated team member to join our Sponsor dedicated team as junior CRA. At this position you will have the opportunity to put your passions to work in an environment designed to help you gain experience in a wide ...
-
Clinical Trial Assistant- Sponsor Dedicated
hace 2 semanas
Sdi Digital Group Madrid, EspañaClinical Trial Administrator, Single Sponsor dedicated · Job Overview : CTA performs daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. · By assisti ...
-
Clinical Trial Assistant- Sponsor Dedicated
hace 5 días
IQVIA Madrid, España De jornada completaClinical Trial Administrator, Single Sponsor dedicated · Job Overview: · CTA performs daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. By assisti ...
Senior Regulatory Medical Writer, sponsor-dedicated - Alcobendas, España - Fortrea
Descripción
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
WHAT YOU WILL DO
Imbedded in the team of one of the world ́s leading pharma companies, you will be one of the primary , project leading the Development Cycle for high-complexity Phase II-IV clinical regulatory documents.
We ́ll trust you to spearhead the entire process, from initial planning and coordination through all stages of development, culminating in the final delivery to the sponsor.
From the variety of documents you will work on (Investigator ́s Brochures, Safety Narratives, ICFs, Efficacy Summaries, Regulatory responses, etc.,) your contribution will be essential developing:
With minimal supervision, during Planning stage , you will:
During document development , you will:
Once final data is received:
WHO YOU WILL WORK WITH
You will coordinate functional leads and reviewers from the Biostatistics, Data Management, Programming, Clinical Leadership and Project Physician teams. Additionally, you will engage with Medical Writing teams across Europe, and also the Americas and Asia-Pacific.
LOCATIONS
This is a full-time , permanent job.
Our ideal locations are: UK, Spain, Germany and France .
YOUR EXPERIENCE
PERSONAL/TEAM SKILLS
You ́ll be the nexus where multiple teams ́ expertise converge:
To drive development of documents of this scale forward, this role requires visibility, proactivity, collaboration/teamwork, and excellent communication skills.
Integration within the client ́s team is crucia l:
A UNIQUELY DIVERSE CAREER
At Fortrea, we empower you to shape your own career path.
Whether you are passionate about the medical writing scientific side, or aspire to leadership roles, we provide comprehensive training, management support, a network of SME's and KOL's and opportunities to help you thrive.
Your aspirations drive your journey with us. Where do you see yourself?
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
