Senior Medical Writer (SMW)

Excelya>Full-time>Senior Medical Writer (SMW)

Job description

Created in 2014, Excelya is a contract research organization (CRO).
We offer a personal and authentic experience within an ambitious young healthcare company on its way to becoming the leader in clinical research in Europe with our 800 Excelyates. Our unique one-stop provider service model – leveraging a full-service, functional service provider and consultancy – allows our Excelyates to evolve across a wide range of projects. Working with leading experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means enjoying a challenging professional environment that encourages personal, intellectual and operational participation so that together we can be the best in our field. We are committed to empowering each Excelyate to express their natural talents, develop their full potential and invest in our unique

Mission
Perform – with experienced & well-defined input – medical writing on the study and other scientific documents:

  • To acknowledge and strictly comply with the sponsors’ and Excelya’s SOPs, guidelines and appropriate local and international legislation. To keep him-self/herself continuously informed on any amendments or updates of the above-mentioned guidelines, applicable laws and procedures
  • To design and coordinate the performance of the literature review accord-ing to the project’s requirements for its effective completion and according to the sponsors’ and Excelya’s SOPs
  • With minimal support, to design, coordinate, write and review medical writ-ing deliverables [including clinical study protocols and clinical protocol amendments, informed consent forms, clinical study reports, clinical evalu-ation reports, common technical dossier (CTD) submissions, Investigator Brochures, Lay Summaries as well as clinical journal manuscripts, clinical journal abstracts, posters, literature reviews and client presentations] ac-cording to the sponsors’ and Excelya’s SOPs
  • To liaise with other functional groups or departments (e.g., data manage-ment, statistical programming, biostatistics, project management) to en-sure timely delivery and quality of writing deliverables
  • To liaise with sponsors to negotiate changes where necessary 6. To maintain familiarity with current industry practices and regulatory re-quirements and guidelines that affect medical writing 7. To mentor and lead less experienced Medical Writers on complex projects, as necessary
  • To support the Principal Medical Writer with the coordination of other Med-ical Writers or Senior Medical Writers
  • To act as a backup to other Senior Medical Writers and Medical Writers when needed
  • To assist to any other project or other functions (Medical Advisor, Medical Monitor) of the Medical Affairs Department as requested by the superior

Requirements:

The assignment requires the following skills:

  • University graduate in life sciences or equivalent (postgraduate studies in a relative field are considered as a plus)
  • A relative experience of 3 years to 5 years in medical writing is considered a plus
  • CTC, Upto 15Lac
  • Analytical skills and ability to interpret data
  • Attention to detail
  • 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 of English
  • Strong knowledge of ICH regulations, and CONSORT, STROBE and PRISMA guidelines
  • Interpersonal and leadership skills

Summary

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