Principal Medical Writer, Regulatory Affairs Specialist

4 days ago

London, Greater London, United Kingdom BIOMARIN Full time
Job Title: Principal Medical Writer, Regulatory

At BioMarin, we are committed to developing innovative treatments for rare genetic diseases. We are seeking a highly skilled Principal Medical Writer, Regulatory to join our team and contribute to the development of our pipeline of commercial, clinical, and preclinical candidates.

Responsibilities:
  • Provide functional oversight for medical writing staff and ensure timely delivery of high-quality documents.
  • Collaborate with the Head of Medical Writing to establish and maintain project timelines and ensure alignment with organizational goals.
  • Author and edit documents used in conducting and reporting clinical studies, including protocols, informed consent forms, and clinical study reports.
  • Develop and maintain regulatory documents, such as investigator's brochures and periodic safety reports.
  • Manage study team participation in document preparation, including scheduling meetings, developing timelines, and managing document review and comment adjudication processes.
  • Provide peer review and editing support for other regulatory documents, such as statistical analysis plans and CRFs.
  • Assist in developing and reviewing standard processes and templates within Clinical Medical Writing.
Requirements:
  • At least 8 years of experience as a medical writer in the pharmaceutical industry.
  • Advanced applied knowledge of routine document content preparation, including style guides, medical dictionaries, and guidance documents.
  • Ability to interpret and create complex tabular and graphical clinical data presentations.
  • Understanding of coding dictionaries (MedDRA, WHO Drug).
  • Proficient in Microsoft Office, including Word, Excel, and PowerPoint.
  • Experience using document management software, such as SharePoint or Veeva.
What We Offer:

At BioMarin, we offer a dynamic and supportive work environment, competitive compensation and benefits, and opportunities for career growth and development. If you are a motivated and detail-oriented medical writer with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.

  • Principal Medical Writer, Regulatory Affairs Specialist

    7 days ago

    London, Greater London, United Kingdom BIOMARIN Full time

    Job Title: Principal Medical Writer, RegulatoryAt BioMarin, we are committed to developing innovative treatments for rare genetic diseases. We are seeking a highly skilled Principal Medical Writer, Regulatory to join our team and contribute to the development of our pipeline of commercial, clinical, and preclinical candidates.Key Responsibilities:Provide...

  • Principal Medical Writer, Regulatory Affairs Specialist

    7 days ago

    London, Greater London, United Kingdom BIOMARIN Full time

    Job Title: Principal Medical Writer, RegulatoryAt BioMarin, we are committed to developing innovative treatments for rare genetic diseases. We are seeking a highly skilled Principal Medical Writer, Regulatory to join our team and contribute to the development of our pipeline of commercial, clinical, and preclinical candidates.Key Responsibilities:Provide...

  • Senior Medical Writer, Regulatory

    5 days ago

    London, Greater London, United Kingdom BioMarin Pharmaceutical Inc. Full time

    Job Title: Principal Medical Writer, RegulatoryAbout the Role:We are seeking a highly skilled and experienced Principal Medical Writer, Regulatory to join our Clinical Development team at BioMarin Pharmaceutical Inc. As a key member of our team, you will be responsible for providing medical writing support for clinical development programs, including...

  • Senior Medical Writer, Regulatory

    4 days ago

    London, Greater London, United Kingdom BioMarin Pharmaceutical Inc. Full time

    Job Title: Principal Medical Writer, RegulatoryAbout the Role:We are seeking a highly skilled and experienced Principal Medical Writer, Regulatory to join our Clinical Development team at BioMarin Pharmaceutical Inc. As a key member of our team, you will be responsible for providing medical writing support for clinical development programs, including...

  • Regulatory Affairs Specialist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:As a Regulatory Affairs Specialist, you will work under the supervision of an experienced regulatory manager, providing regulatory support to a wide range of chemical products. You will be...

  • Regulatory Affairs Specialist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:As a Regulatory Affairs Specialist, you will work under the supervision of an experienced regulatory manager, providing regulatory support to a wide range of chemical products. You will be...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...

  • Regulatory Affairs Specialist

    2 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA unique chance to launch your career in chemical regulatory affairs with VRS Regulatory, a specialist scientific recruiter.About the Role:Work under the guidance of an experienced regulatory manager to provide support for a diverse range of chemical products.Conduct a variety of activities, including SDS authoring, updates,...

  • Regulatory Affairs Specialist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support for a wide range of chemical products.Conduct a range of activities, including SDS authoring,...

  • Regulatory Affairs Specialist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support for a wide range of chemical products.Conduct a range of activities, including SDS authoring,...

  • Regulatory Affairs Specialist

    1 day ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product portfolio,...

  • Regulatory Affairs Specialist

    24 hours ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs OpportunityA rare chance to start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product portfolio,...

  • Regulatory Affairs Specialist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kick-start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product...

  • Regulatory Affairs Specialist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kick-start your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the supervision of an experienced regulatory manager to provide regulatory support to a wide range of chemical products.Conduct a range of activities to support a broad product...

  • Regulatory Affairs Specialist

    3 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • Regulatory Affairs Specialist

    3 weeks ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Job DescriptionA rare opportunity for an aspiring regulatory affairs professional to join the regulatory team at a global chemical products business:Work under the supervision of an experienced regulatory managerProvide regulatory support to a wide range of chemical productsOngoing and comprehensive trainingAn excellent opportunity to start and establish...

  • Regulatory Affairs Specialist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the guidance of an experienced regulatory managerProvide regulatory support for a diverse range of chemical productsParticipate in ongoing and comprehensive trainingYou will be...

  • Regulatory Affairs Specialist

    6 days ago

    London, Greater London, United Kingdom VRS Regulatory Full time

    Regulatory Affairs Officer OpportunityA rare chance to kickstart your career in chemical regulatory affairs with a global chemical products business.Key Responsibilities:Work under the guidance of an experienced regulatory managerProvide regulatory support for a diverse range of chemical productsParticipate in ongoing and comprehensive trainingYou will be...

  • Regulatory Affairs Manager

    3 days ago

    London, Greater London, United Kingdom Turner Regulatory Full time

    Principal Regulatory Officer / EU; Pharma & Generic Products / Project ManagerTurner Regulatory is seeking a highly skilled Principal Regulatory Officer to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.Key...

  • Regulatory Affairs Manager

    3 days ago

    London, Greater London, United Kingdom Turner Regulatory Full time

    Principal Regulatory Officer / EU; Pharma & Generic Products / Project ManagerTurner Regulatory is seeking a highly skilled Principal Regulatory Officer to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and providing strategic guidance on regulatory matters.Key...