Medical Writer - Danish

Firmabeskrivelse

translate plus, an award-winning Top 10 international Language Services Provider, including Top 3 in the EU and Top 2 in the UK, is a Publicis Groupe company, one of the most well-established advertising corporations globally. translate plus sits within the network's cross-media production platform, Publicis Production. This brings together production specialists who are experts in: video, digital media, and print, to produce award-winning content for leading global brands.

Recent recognition awards for translate plus include an award for "Great Employers", and an award for "Women in Business", more details can be found on our website regarding these two great achievements.

translate plus also promotes numerous employee well-being policies across all our offices, which align with Publicis Groupe guidelines. We offer WFH flexibility to all employees as well as relevant programs to help promote mental and physical well-being.

translate plus is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion, belief, ethnic or national origin, disability, age citizenship, marital, domestic, or civil partnership status, sexual orientation, or gender identity.

Jobbeskrivelse

Job Description:

On behalf of our client, We are seeking a Medical Writer, native Danish speaker, to join our team for 3 months (FTC). Additionally, we welcome applicants based in London or those interested in remote work from Denmark 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

• Danish native speaker - Mandatory

Kvalifikationer

Yderligere oplysninger