Current jobs related to Lead Clinical Document Developer - Dublin, Dublin City - beBee Careers

  • Clinical Study Documentation Lead

    2 days ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    As a Senior Medical Writer, you will play a key role in the development of clinical study documents, including protocols, CSRs, and IBs.You will work closely with cross-functional teams to ensure that all documents are accurate, complete, and meet regulatory requirements.Your responsibilities will include authoring study-level documents independently,...

  • Clinical Documentation Lead

    5 days ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    About the RoleThe successful candidate will serve as a key leader in the medical writing function, overseeing all aspects of clinical documentation.

  • Clinical Document Specialist

    5 days ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Clinical Document Specialist">In this role, you will be responsible for creating clear and concise clinical and regulatory documents. This includes managing document templates, reviewing statistical outputs, and driving the review process.">We are looking for a candidate with an advanced degree in a relevant scientific or clinical field and at least 5 years...

  • Clinical Documentation Specialist

    1 week ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Are you looking for a new challenge in clinical document review and approval? We have an exciting opportunity for a Central Integrated Scientific Review Committee Lead to join our team.About the RoleThis role plays a key part in ensuring high-quality documents are reviewed and approved across various therapeutic areas.The ideal candidate will have strong...

  • Clinical and Regulatory Document Developer

    4 days ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    As a Senior Medical Writer, you will play a critical role in developing high-quality clinical and regulatory documents that meet all regulatory requirements and industry standards.About the RoleWe are seeking an experienced medical writer to join our team in Europe. The ideal candidate will have a strong background in regulatory writing and experience...

  • Clinical Documentation Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    We are seeking a highly skilled Clinical Documentation Specialist to join our dynamic team. As a key member of our global team, you will be responsible for preparing clinical documentation for regulatory submissions.You will have the opportunity to develop expertise in the preparation of a wide range of documents, including clinical study reports, protocols...

  • Senior Clinical Document Developer

    4 days ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    We are seeking a skilled Principal Medical Writer to join our team in developing clinical documents for submissions to regulatory authorities globally.",

  • Clinical Development Lead

    7 days ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    The ideal candidate for this role is a seasoned professional with a strong background in clinical research and drug development. With a minimum of 5 years of experience, they will have a deep understanding of clinical trial design, statistics, and regulatory processes.They will also possess excellent leadership skills, with the ability to manage...

  • Lead Medical Writer

    5 days ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Job Title: Senior Medical Writer - Regulatory DocumentsDescription:We are seeking an experienced Senior Medical Writer to join our team as a Regulatory Document Specialist. In this role, you will be responsible for leading the development of medical writing documents, including coordinating assignments with writers, reviewing and editing documents, and...

  • Clinical Document Specialist

    7 days ago

    Dublin, Dublin City, Ireland beBee Careers Full time

    Senior Medical Content DeveloperYou will contribute to the creation of high-quality clinical and regulatory documents, utilizing expertise in clinical drug development.The ideal candidate will have excellent writing skills, be able to interpret clinical and scientific data, and present results clearly. Knowledge of current submission guidelines and...

Lead Clinical Document Developer

2 weeks ago

Dublin, Dublin City, Ireland beBee Careers Full time

Job Summary

">

This is a challenging and rewarding opportunity for a Lead Clinical Document Developer to join our team. The successful candidate will be responsible for developing high-quality clinical documents for submission to regulatory authorities globally.

">

The ideal candidate will have solid experience as a Principal Medical Writer, gained from a CRO or Pharma company, with a strong background in clinical document development and regulatory submissions. They will be able to develop and review clinical study protocols, reports, and other documents in accordance with ICH and global guidelines.

">

The successful candidate will also have excellent project management skills, including a deep understanding of clinical timelines and interdependencies among groups. Strong verbal, written, and interpersonal communication skills are essential to work effectively in a team environment.

">

Key Responsibilities

">
  • ">
  • Develop and review clinical study protocols, reports, and other documents in accordance with ICH and global guidelines">
  • Oversee the medical writing activities of multiple compounds and serve as lead writer for individual summary documents">
  • Mentor and lead less experienced medical writers on complex projects">
  • Develop good working relationships with internal and external colleagues">
  • Participate in cross-functional process improvement initiatives">
">

Requirements

">
  • ">
  • Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree">
  • Solid experience as a Principal Medical Writer gained from a CRO or Pharma company">
  • Excellent project management skills, including a deep understanding of clinical timelines and interdependencies among groups">
  • Strong verbal, written, and interpersonal communication skills to work effectively in a team environment">
  • Proficient understanding and knowledge of global regulatory requirements and therapeutic areas in all phases of clinical development">
  • Demonstrated effective presentation, proofreading, and interpersonal skills, ensuring a team-oriented approach">
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet">
  • Ability to demonstrate familiarity with principles of clinical research and interpret and present complex information">
">

About Our Company

">

We are a global leader in the biopharmaceutical industry, providing innovative solutions to accelerate customer success. Our mission is to put the customer and patient at the center of everything we do.

">

We are committed to building a diverse, inclusive, and authentic workplace, where you can bring your whole self to work every day. At Syneos Health, we value transferable skills from previous roles and welcome applicants who may not meet the exact qualifications but have relevant experience.

">

We are an Equal Opportunity Employer, committed to fair and equitable hiring practices. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability, or any other legally protected status.