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Medical Writer - Netherlands  

Company managed [?] Still accepting applications

Posted on : 30 March 2017

Project Description

 
What we offer!
  • We offer an exciting and innovative working environment within a very committed start-up organization, great colleagues and a lot of fun! 
  • We believe in our strong culture; personal responsibility, flexible work hours and places.
  • Off course we pay a good salary. 
  • You will have a training budget and we will pay your pension and you will get travel allowance. 
  • Do you think you can contribute in achieving our mission 
  • Do you want to work in challenging environment where your work can really make a difference?
  • We are looking for you.




What are you going to do: 
The Medical Writer will be responsible for the preparation, writing, and review of the scientific and regulatory documentation needed in support of research and development activities, including clinical trials and corresponding submissions to regulatory authorities, up to NDA filings.
This position will report to the Vice President, Regulatory Affairs, and be part of the Clinical Research Development Organization. 
Operating independently, under the broad guidance of the VP, the medical writer will be primarily responsible for the following:
  • Coordinate and oversee all writing activities for the projects he/she is supporting 
  • Develop medical writing processes, standards, and improvement initiatives 
  • Provide the appropriate background information, guidance, and training to any writer producing documents to support their tasks 
  • Write regulatory documents including, but not limited to, Investigator’s Brochures, Protocols, Clinical Study Reports, Nonclinical and Clinical Summary Documents, and Briefing Documents 
  • Provide overall medical writing support for the projects and programs (eg, manuscripts, abstracts, SOPs) as needed 
  • Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents and ensure consistency between related documents and improve overall document quality 
  • Serve as the lead medical writer on multiple programs; attend team meetings and contribute to program goals, key messages, and timeline discussions 
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables 
  • Review documents, including those authored by others both internally and externally 
  • Perform and/or manage quality control reviews of regulatory documents 
  • Ensure clinical documents adhere to standards and regulatory guidelines.



We Ask:
  • At a minimum, a B.A./B.S. degree; PhD/PharmD in life sciences preferred 
  • At least 3-5 years of relevant industry experience as a regulatory medical writer 



Experience and Skills:
  • Excellent writing and communication skills 
  • Strong interpersonal skills; a team player 
  • Flexibility to function well within a team environment and within condensed timelines 
  • Strong project management and organizational skills 
  • Understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology 
  • Ability to comply with company and/or industry style guides and templates 
  • Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy 
  • Technical expertise in Microsoft Word, Adobe Acrobat 




Opportunity:
  • Do you want to be part of our devoted team of enthusiastic professionals?
  • Do you think you can contribute in achieving our mission? 
  • Do you want to work in challenging environment where your work can really make a difference?
  •  If so, we’re looking forward to receive your application.