Experienced Medical Writer

Emtex BV; United States; Hybrid; USD 67,000 - 101,000; Full time

Benefits offered by this job

Company car

Job summary

Emtex BV is seeking an Experienced Medical Writer to prepare and coordinate clinical and regulatory documents such as Investigator Brochures, CSRs, and Protocols. You will ensure high quality, regulatory-compliant output and manage document reviews for clients in pharma, biotech, medical device and CRO settings.

The role requires 3–5 years in Regulatory Medical Writing, a Master’s degree in a scientific discipline, and fluent English with Dutch at C1+ level.

Qualifications

• Master’s degree in a scientific discipline (biological, veterinary, pharmaceutical or medical sciences) preferred.
• 3–5 years hands-on experience in Regulatory Medical Writing.
• Excellent written and spoken English; Dutch language skills (C1+).

Responsibilities

• Write regulatory documents (Investigator Brochures, Clinical Study Reports, Protocols, Clinical Summaries) to regulatory standards.
• Coordinate and manage document review processes with internal teams and clients.
• Lead literature reviews and ensure all documents comply with FDA/EMA guidelines and company SOPs.

Job description

EMTEX is an independent and compact company that offers professional medical writing and related services all around the world to the pharmaceutical (human & veterinary), biotech, medical device and other industries, CROs and academic institutions. We have a long track record in supporting our customers with dedicated services. As we would like to expand our international services, grow and strengthen our team, we have a job opening for an Experienced MedicalWriter.

JOB DESCRIPTION

Successful candidates will be responsible for the preparation and coordination of a wide range of clinical and regulatory documents, including Investigator Brochures, Clinical Study Reports, Clinical Trial Protocols, Clinical Summaries of Efficacy and Safety and Clinical Overviews. The documents must be of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency, and must adhere to regulatory guidelines and company styles and processes.

JOB TYPE

Full-time (40 hours per week); in office/home office.

PRIMARY LOCATION

Belgium (in office+home office) or The Netherlands (home office)

ROLES & RESPONSIBILITIES

• Write clear, concise and consistent simple or complex documents compliant with the needs of the regulations or questions of the authorities, as appropriate.
  • Perform literature searches/reviews as necessary to obtain background information and training for development of documents
  • Carry out novel or complex assignments with minimal assistance
  • Model a rigorous and disciplined approach to medical writing
  • Ensure that all work is complete and of high quality
  • Ensure document content and style adhere to FDA/EMA or other appropriate regulatory guidelines, and comply with internal and client SOPs/WIs and style guidelines
  • Orchestrate an effective and efficient document review process
  • Attend or lead internal and client team meetings as required
• Perform peer review of draft documents prepared by other Medical Writers before external distribution when requested.
• Initiate and participate in process improvement and training initiatives, and assist in the development of SOPs/WIs.
• Assist with project management for a limited number of projects.
• Act as primary client contact for a limited number of projects.
• Perform Quality Control checks of documents.

EDUCATION

A minimum of a Master’s degree in a scientific discipline (a degree in biological, veterinary, pharmaceutical or medical sciences) is highly preferred.

EXPERIENCE

3-5 years hands‑on experience in Regulatory Medical Writing.

SKILLS & COMPETENCES

• Further improve spoken and written English
• Have a team-oriented attitude
• Act/behave professionally with a client focus
• Be pro‑active
• Always be eager to learn
• Further improve your writing skills
• Take ownership/responsibility of your document
• Be well organized

LANGUAGE

Excellent written and verbal language skills in English and Dutch (C1 or better).

OUR OFFER

We offer a competitive salary package and company car.

CONTACT INFORMATION

Interested? Please send your application letter with an indication of your motivation and experience together with your CV (attn. of Mrs. Griet Van Acker).