Applied Medical

Associate Clinical Writer Manager

Category (Portal Searching) Product Management
Job Locations NL-Amersfoort

Overview

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At Applied Medical, we are committed to make a meaningful, positive difference, each and every day. Within our European headquarters in Amersfoort (NL), we develop, manufacture and support the implementation of our advanced medical devices across Europe and the MENA region. Applied’s team members enjoy working in an environmentally friendly and international environment, in which people of diverse backgrounds are valued, challenged, and acknowledged. We support our team members by giving them opportunities of ongoing learning and education, possibilities to take part in community volunteering activities and a variety of onsite exercise classes and health activities.

 

If you are passionate about working in an organization that allows you to make decisions based upon what is right for the patient, customer, community and environment, Applied Medical is the place for you.

Job Description

We are looking for an Associate Clinical Writer Manager to join our Clinical Development team. You will work within the framework of a collaborative team environment to prepare clinical documents per the European Union Medical Device Regulation as well as other technical documents. In addition, you will collaborate with the Regulatory Affairs team to interpret and provide guidance and structure to the Clinical Development team on regulation requirements for these technical documents. You will analyze, research and make decisions to support the compliance with the Medical Device Regulation requirements.

You will be based at the our European office in Amersfoort (NL) and you will report to the Clinical Development Manager.


Key Responsibilities

  • Lead and assist with the development and completion of scientific plans and reports to ensure compliance with the Medical Device Regulation
  • Become an expert in the Medical Device Regulation requirements related to post market surveillance activities within Applied Medical
  • Support the Clinical Development team in their involvement in post market surveillance activities
  • Develop scientific plans and reports and review them
  • Assist in managing timelines and communications to ensure the team is maintaining compliance with the Medical Device Regulation expectations, milestones and deliverables
  • Research for new external training materials that will assist the team in ensuring compliance with the Medical Device Regulation
  • Create and maintain Standard Operating Procedures, Job Aids and Desk Procedures

Requirements

  • Bachelor’s/Master's degree level
  • 3+ years of experience in a similar or related role
  • Ability to understand and interpret results of clinical studies, with a strong understanding of statistics
  • Expertise in conducting focused literature searches
  • Data analytic publication experience or literature author publication experience
  • Experience with writing medical device documents
  • Good knowledge of MS Office and Windows based computer applications
  • Experience working in an international and multidisciplinary environment is preferred
  • Knowledge of multiple European languages is preferred

We Offer

  • Good remuneration package including pension and 27 vacation days
  • Travel allowance and health insurance benefits
  • Working from home option available
  • Opportunity for personal development and continuous learning
  • Education reimbursement program
  • An informal and international work environment with over 35 nationalities
  • Teambuilding and volunteer opportunities
  • Onsite group exercise classes and health activities
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Interested?

 

Are you an individual who thrives in a fast-paced, challenging, and professional, yet casual business environment? We are looking forward to receiving your application. For more information regarding our hiring process, click here.

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