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 Medical Writer.
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.
Full-time (40 hours per week); in office/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.
A minimum of a Master’s degree in a scientific discipline (a degree in biological, veterinary, pharmaceutical or medical sciences) is highly preferred.
3-5 years hands-on experience in Regulatory Medical Writing.
SKILLS & COMPETENCES
- Have/develop an eye for detail
- Further improve spoken and written English
- Demonstrate excellent computer skills
- Be a good communicator
- 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
Excellent written and verbal language skills in English and Dutch (C1 or better).
We offer a competitive salary package and company car.
Interested? Please send your application letter with an indication of your motivation and experience together with your CV (attn. of Mr. Mario De Witte).