Sr. Medical Writer (CEE – Remote Work)

Excelya>Full-time>Sr. Medical Writer (CEE – Remote Work)

Job description

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

  • Quick development and career growth
  • Competitive remuneration
  • Laptop
  • Medical private insurance

Purpose of the role: The sr. Medical Writer will be involved in all medical and regulatory writing activities, and provide support to other departments and local and international clients on medical issues.

Missions:

  • Compiling, writing, reviewing and editing medical writing deliverables (clinical study protocols and clinical protocol amendments, informed consent forms, clinical study reports, clinical evaluation reports, CTD submissions, Investigator Brochures, as well as clinical journal manuscripts, clinical journal abstracts, posters, literature reviews and client presentations) for a variety of audiences with minimal supervision
  • Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
  • Ensuring the accuracy of all information, data and referencing for the publications/documents produced
  • Working on a variety of projects at the same time
  • Understanding new therapy areas quickly and comprehensively
  • Working closely with clients, physicians and investigators
  • Contributing ideas for business proposals and new projects
  • Mentoring and leading less experienced medical writers on complex projects, as necessary
  • Adhering to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget
  • Maintaining familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing

Profile :

  • Postgraduate qualifications (PhD or Master’s degree) in a life science (biological sciences, biomedical sciences or biochemistry)
  • Prior experience as a medical writer of over 3 years
  • Previous experience working in a CRO will be considered as a plus
  • Experience in writing Protocol, clinical study report (CSR), common technical document (CTD)
  • A strong work ethic
  • Intellectual curiosity and creativity
  • The ability to work effectively in a team in a fast-paced and dynamic environment
  • Advanced level Scientific English
  • Strong knowledge of ICH regulations, and relevant guidelines
  • Interpersonal and leadership skills

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