Remote Medical Writer, Oncology, Scientific & Regulatory Documents (PRA) 168 views

Job Overview

  • Specialty License RN, MSN, ARNP, PMHNP, DNP
  • State License Nationwide

Do you want to watch clinical development change, or do you want to be the one to shape it?

 

Because we’re hoping you’re here for the latter.

 

Who are we?

We Are PRA.

 

We are 17,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting life saving drugs into the hands those who need them most.

 

Who are you?

You are a forward thinker. You are an innovator that refuses to settle. You want to push the boundaries and change not just what it means to be a Medical Writer, you want to change the future.  You want to learn from the best, grow your knowledge and your skill set, and you want to build your career here. You want to use the latest technology and tools in the industry to push the momentum of an already growing company forward. You want to find a balance that still lets you be, well, you. Most of all, you want to do it in a place where you’re more than an employee number. A place you love working.

 

Still here? Good. Because if this is you, we’d really like to meet you.

Responsibilities

What will you be doing?

 

As a Medical Writer, we are looking for an experienced Medical Writer to join the Clinical Operations team. In this role, the Medical Writer will be working closely with our Clinical and Regulatory teams in preparation of scientific and regulatory documents.

 

Job duties include the following:

  • Independently or with minimal supervision write, edit, perform data verification, submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, clinical study reports (CSRs), investigator’s brochures, and safety reports.
  • Perform copy editing for grammar, punctuation, style, and internal consistency.
  • Collaborate effectively with other functional area authors to achieve submission schedules as prioritized by senior management.
  • Administer QC checks to ensure documents comply with FDA guidelines.
  • Help develop and manage medical writing processes, SOPs, and templates for key documents.
  • Help manage the functional review of study documents produced by contract writers.
  • Keep abreast of professional information and technology through literature, symposia, and conferences.
  • Participate in departmental and cross-departmental initiatives. Provide innovation and be a resource for improving departmental processes. Provide expertise and guidance on document design and principles of good medical writing to department and product teams.

Qualifications

What do you need to have?

 

Required Education:

  • Bachelor’s degree in scientific, health-related or journalism/ communications field

 

Required skills:

  • 5 years of experience in science or medical-related writing

Preferred  Qualifications and Education:

  • Bachelor’s degree, preferably in a physical science, life science, or health-related field (biology, chemistry, nursing, etc). Advanced degree (Masters, Doctorate) is a plus but not required.
  • Three to 5 years of directly related experience in a pharmaceutical company or CRO environment supporting regulatory submissions to health authorities, US and/or EU.
  • Experience with SharePoint and Veeva a plus

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