Vacatureomschrijving

Job Description:

On behalf of our client, We are seeking a Medical Writer, Dutch native speaker, to join our team for 3 months (FTC). Additionally, we welcome applicants based in London or those interested in remote work from Turkey as we are looking for a medical writer who has expertise in healthcare and pharmaceutical industries by translating complex scientific and clinical information into clear and concise documents. Their primary responsibility is to communicate medical and scientific information to various audiences, including healthcare professionals, regulatory agencies, and the public.

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, including healthcare professionals, patients, and the general public.

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

Functie-eisen