Senior Medical Document Specialist
3 weeks ago
Job Title: Medical Writer
Job Summary:
We are seeking a skilled Medical Writer to join our team at Translate Plus. As a Medical Writer, you will be responsible for communicating complex scientific and medical information to various audiences, including healthcare professionals, regulatory agencies, and the public.
Key Responsibilities:
Clinical and Regulatory Writing:
• Prepare and edit clinical study protocols, clinical study reports, investigator brochures, and other regulatory documents for submission to health authorities.
• Ensure that these documents comply with regulatory guidelines and standards.
Publication Writing:
• Contribute to the development of manuscripts, abstracts, and posters for publication in scientific journals and presentations at conferences.
• Collaborate with researchers and authors to gather data and ensure accuracy in publications.
Scientific Communication:
• Communicate complex scientific and medical information in a clear and understandable manner for diverse audiences.
Drug Safety Documents:
• Prepare safety-related documents such as periodic safety update reports (PSURs), risk management plans, and other safety documents required for regulatory submissions.
Clinical Trial Disclosure:
• Assist in the preparation of clinical trial disclosure documents, including results summaries for posting on clinical trial registries.
Regulatory Submissions:
• Collaborate with cross-functional teams to compile and write sections of regulatory submissions, such as New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), and Investigational New Drug (IND) applications.
Required Skills:
• 10+ years medical writing experience.
• PHD is preferred.
• Dutch native speaker - Mandatory.
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