Regulatory Medical Writer Leader

hace 3 días


Madrid, Madrid, España Be-It A tiempo completo

Be-It, the world's largest clinical research organization, is seeking an experienced Regulatory Medical Writer to lead our drug development efforts.

We offer a comprehensive and competitive total reward package, including $120,000 base salary, variable pay, recognition programs, best-in-class employee benefits, supportive policies, and wellbeing initiatives. Our success depends on the knowledge, capabilities, and quality of our people. We are committed to developing our employees in a continuous learning culture.

The ideal candidate will have 5-6 years of experience in regulatory medical writing, with at least 4 years of writing submission documents for safety summaries, efficacy summaries, and clinical overviews, preferably in oncology. A Master's degree in natural sciences is preferred, but strong candidates with a Bachelor's degree will also be considered.

This role involves leading cross-functional writing teams supporting high-priority drug projects, developing regulatory submission content strategy, and maintaining current knowledge on all regulatory agency medical review guidelines and drug approval requirements.

Candidate Requirements:

  • 5-6 years of experience in regulatory medical writing
  • At least 4 years of experience writing submission documents
  • Strong understanding of the overall drug development process
  • Mastery of clinical study report development, regulatory and drug safety requirements, and clinical data management and statistical processes

  • Medical Writer Leader

    hace 2 semanas


    Madrid, Madrid, España Syneos Health A tiempo completo

    Job SummarySyneos Health, a leading biopharmaceutical solutions organization, seeks an experienced Senior Medical Writer Leader to join our team. In this critical role, you will oversee complex writing projects, mentor junior writers, and coordinate activities across departments with minimal supervision.About UsWe are a fully integrated organization...


  • Madrid, Madrid, España Icon A tiempo completo

    Company Overview: At Icon, we strive to provide comprehensive and competitive total reward packages that cater to our employees' needs. Our focus is on delivering an excellent level of base pay, accompanied by a wide range of variable pay and recognition programs.Estimated Salary: $120,000 - $150,000 per year, depending on experience and location.Job...


  • Madrid, Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completo

    Job Title: Senior Medical Writer SpecialistAbout the Role:This Senior Medical Writer Specialist position at Syneos Health is a fantastic opportunity for experienced medical writers to join our Clinical and Corporate - Prod team. As a Senior Medical Writer Specialist, you will be responsible for mentoring and leading less experienced medical writers on...


  • Madrid, Madrid, España Med Communications International A tiempo completo

    **Job Title:** Pharmaceutical Communications Specialist - Medical Writer**Estimated Salary:** $80,000 - $120,000 per yearCompany Overview: At Med Communications International, we strive to provide accurate and balanced scientific information to internal stakeholders, external healthcare professionals, and consumers in a way that supports business needs; is...

  • Medical Writer and Editor

    hace 2 semanas


    Madrid, Madrid, España Syneos Health, Inc. A tiempo completo

    About the Position:We are seeking an experienced Medical Writer and Editor to join our team. As a Medical Writer and Editor, you will be responsible for creating high-quality clinical documents, editing and revising written content, and ensuring compliance with regulatory requirements.About Us:Syneos Health, Inc. is a leading integrated biopharmaceutical...

  • Senior Medical Writer

    hace 2 meses


    Madrid, Madrid, España Icon A tiempo completo

    About the RoleWe are seeking a highly skilled Senior Medical Writer to join our team at ICON. As a key member of our clinical documentation team, you will be responsible for writing and editing high-quality clinical documents in support of regulatory submissions.Key ResponsibilitiesDevelop and implement clinical content strategies for assigned projectsAuthor...

  • Senior Medical Writer

    hace 3 semanas


    Madrid, Madrid, España Syneos - Clinical and Corporate - Prod A tiempo completo

    Job 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...

  • Senior Medical Writer

    hace 2 semanas


    Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    About the RoleAs a Senior Medical Writer at Syneos Health, you will be responsible for leading complex medical writing projects and mentoring less experienced writers. Your key responsibilities will include developing and managing various documents such as clinical study protocols, reports, patient narratives, and regulatory submissions.Key...

  • Senior Medical Writer

    hace 2 semanas


    Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    Experience the thrill of shaping the future of healthcare as a Senior Medical Writer at Syneos Health. We are passionate about developing innovative solutions that accelerate customer success and make a meaningful difference in people's lives.About UsSyneos Health is a leading biopharmaceutical solutions organization built to drive customer success. Our...

  • Senior Medical Writer

    hace 2 meses


    Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    Role SummaryAs a Senior Medical Writer at Syneos Health, you will play a pivotal role in developing high-quality clinical content for our clients. You will work closely with cross-functional teams to create compelling narratives that drive project success. This is an excellent opportunity to leverage your writing expertise and passion for healthcare to make...

  • Medical Writer Specialist

    hace 3 semanas


    Madrid, Madrid, España Syneos Health A tiempo completo

    Job SummaryWe are seeking a Medical Writer Specialist to join our Clinical Development team at Syneos Health. As a key member of our team, you will be responsible for mentoring and leading less experienced medical writers on complex projects, representing the Medical Writing department on clinical study teams, and advising clients and study teams on data...


  • Madrid, Madrid, España Syneos Health A tiempo completo

    **Job Overview**Syneos Health, a leading biopharmaceutical solutions organization, is seeking an experienced Senior Medical Writer Lead to accelerate customer success. As a key member of our Clinical Development team, you will work collaboratively with passionate problem solvers to innovate and deliver high-quality writing services.**Estimated Salary:...


  • Madrid, Madrid, España Engineeringuk A tiempo completo

    Company 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 Writer

    hace 2 días


    Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    Unlock a rewarding career with Syneos Health, a leading biopharmaceutical solutions organization accelerating customer success. As a Senior Medical Writer, you'll play a crucial role in translating complex clinical, medical affairs, and commercial insights into actionable outcomes.We're committed to simplifying and streamlining our work to make Syneos Health...


  • Madrid, Madrid, España Sgs A tiempo completo

    Job OverviewSgs is seeking a highly experienced Global Medical Service Leader to lead our medical devices business and drive its growth globally. As a key member of the Global Business Assurance Leadership team, you will be responsible for developing and implementing a fully global commercial strategy for this business area. You will also oversee the...


  • Madrid, Madrid, España Itex A tiempo completo

    About ItexItex is a global leader in producing high-tech medical and aesthetic devices, recognized for its use of valuable materials and sophisticated design. With offices and manufacturing facilities worldwide, this international company is at the forefront of innovation in its field.Job OverviewAs a Regulatory Compliance Specialist, you will play a...

  • Medical Writing Lead

    hace 2 semanas


    Madrid, Madrid, España Syneos - Clinical And Corporate - Prod A tiempo completo

    Lead 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...

  • Junior Medical Writer

    hace 2 días


    Madrid, Madrid, España Oncologypipeline A tiempo completo

    We are seeking a highly motivated Junior Medical Writer to join our team at Oncologypipeline in Madrid.Job Details:Working day: Full-timeLocation: MadridOncologypipeline is rapidly growing and looking for trainees who can quickly become experts in Oncology & Hematology, learn about the scientific progress, key companies, and their pipelines, and acquire the...


  • Madrid, Madrid, España Cpl Healthcare A tiempo completo

    Exciting Opportunity in Regulatory AffairsCpl Healthcare is seeking an experienced Regulatory Affairs Director to lead our medical device lifecycle management efforts. This is a full-time, permanent position based in Madrid, Spain.About the RoleIn this role, you will be responsible for strategic lifecycle management of our medical devices post-CE approval...


  • Madrid, Madrid, España Johnson & Johnson A tiempo completo

    Company 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...