Junior Medical Writer

Emtex BV; United States; Hybrid; USD 36,000 - 58,000; Full time

Benefits offered by this job

Competitive salary package

Job summary

EMTEX is an independent and compact company offering professional medical writing and related services worldwide to the pharmaceutical, biotech, medical device and other industries, CROs and academic institutions. We have a job opening for a Junior Medical Writer.

Successful candidates will assist in preparing a wide range of clinical and regulatory documents and ensure high quality content, clarity and regulatory compliance under supervision.

Qualifications

• Master’s degree in a scientific discipline is highly preferred.
• A passion for writing is key and experience is advantageous.
• Excellent written and verbal language skills in English and Dutch.

Responsibilities

• Assist more experienced Medical Writers in preparing simple documents.
• Under supervision, write clear, concise documents compliant with regulations and client needs; perform literature searches and background checks.
• Coordinate or lead internal and client team meetings and manage the document review process.
• Perform Quality Control checks of documents.

Skills

English proficiency

Dutch proficiency

Team player

Client-focused

Proactive

Willing to learn

Writing skills

Organized

Ownership

Education

Master’s degree in scientific discipline

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 a Junior Medical Writer.

JOB DESCRIPTION

Successful candidates will assist in the preparation 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 (Sint-Gillis-Waas) or The Netherlands

ROLES & RESPONSIBILITIES

• Assist more experienced Medical Writers in the preparation of simple documents.
• Supported by a Senior or Specialist Medical Writer, write clear, concise, and consistent simple 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
  • Model a rigorous and disciplined approach to medical writing
  • Ensure that all work is complete and of high quality (and adhere to the instructions from the more experienced Medical Writer)
  • 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
  • Attend (or lead) internal and client team meetings as required
  • Orchestrate an effective and efficient document review process
• 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

Relevant experience will be considered an advantage.A pronounced passion for writing is key!

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.