Medical Writer

Remote
Full-Time
Part-Time
Internship
First Some Stuff on Us:

We recognize that employees look and feel different in every company, so it’s important to first describe the principles that will drive success in the role prior to talking about the specific responsibilities and tasks. These are: 
1. An obsessive focus on the customer 
2. Being accountable to the customer as if we were their own employee
3. Understanding that strategy is only as good as the execution - and vice versa 
4. Placing a high value on teamwork
5. People are at the heart of the product

In short, we want to build a big but small company.

PERKS:
Amazing culture: Happy, Helpful, Humble, Hungry.
Get to work in one of the fastest growing industries in TX – Life Sciences
Part of an amazing team
Flexible time off with pay
Opportunity for growth!

We know that diversity makes for the best problem-solving and creative thinking. We are dedicated to adding new perspectives to the team and encourage everyone to apply if your experience is close to what we are looking for.  

Equal
 Opportunity Employer: Proxima is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

job DESCRIPTION

The quality of our work is evidenced in our written work product. As a Medical Writer, you will be responsible for authoring important documents for the clinical operations, regulatory affairs, and business development teams.

A Day In the life

·   The medical writer will be responsible for writing a number of different documents across multiple teams.  The medical writer will be expected to work across clinical, regulatory and business development teams.  Below are a few examples of the types of products that the Medical Writer will author:

  • Clinical synopsis, abstracts, clinical protocols, investigator brochures, instructions for use, clinical study reports, supporting documents for both medical device and pharmaceutical product submissions including 510k/BDD/PMA/DeNovo/IND/NDA/BLA filings, and study considerations for business development proposals.

·   Occasional content for marketing activities

·   Review other associates work product for quality and form

     
Must Have Knowledge and Skills
  • A solid scientific and/or clinical foundation
  • BS degree required with significant work experience but prefer advanced clinical or scientific degree (BSN, RN, MS, MPH,PhD) in allied health science fields such as nursing, pharmacy, or natural science or equivalent work experience
  • Strong ability to manage multiple projects simultaneously
  • Ability to work across multiple therapeutic areas     (oncology, cardiovascular, neuroscience, pediatrics, etc.)
  • Ability to prioritize multiple projects and hit deadlines
  • At least 2 years of direct and relevant medical, scientific or regulatory writing experience
  • Knowledge of clinical trial operations and execution
  • Work independently
  • Premium on first draft results
  • Good oral and written communication skills
  • Ability to articulate issues and work directly with clients
  • Self-management skills, including the ability to multi-task
  • Attention to detail and accuracy in work
  • Proficient in Microsoft Word, PowerPoint, Excel, and other Office applications
Nice to Have Knowledge and Skills
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