Medical Writer

Hiring By - Biostaffic

 BioPharma

Job Highlights

Not Disclosed

Remote Job

Mid-Senior level

Posted 4 months ago
Job details

Title: Medical Writer

Location: Remote | based in IL

Pay: $50-59/hr

Contract: 12+ months


Summary

  • The Senior Medical Writer is responsible for providing medical writing, ensuring successful preparation of high quality documents and effective implementation of the writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with cross-functional groups to ensure accurate and timely completion/delivery of information and review of writing projects.


Responsibilities

  • Serves as medical writing lead on assigned projects. Works closely with in-function and cross-functional team(s) on project strategies. Implements all activities related to the preparation of writing projects
  • Coordinates the review, approval, and other appropriate functions involved in the production of writing projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
  • Converts relevant data and information into a form that meets project requirements. Explains data in manner consistent with the target audience(s) requirements.
  • Effectively communicates deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
  • Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams. Interprets and explains data generated from a variety of sources. Verifies that results are consistent with protocols. Challenges conclusions when necessary. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements, as needed for each writing project following applicable divisional guidelines, templates, and SOPs.
  • Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to writing project.
  • Works with journal/congress throughout the writing process, addresses questions/feedback, as appropriate, and works with team to draft responses as necessary.
  • Knowledgeable of US and international regulations, requirements and guidance associated with preparation of writing projects. Learns and applies knowledge of therapeutic area and product to writing projects. Must continually train/be compliant with all current industry requirements as they relate to assigned projects , including submission/approval standards.
  • Serves as a representative on project teams. Acts as Subject Matter Expert regarding computer-based technologies utilized by the respective departments. May mentor and provide guidance to more junior medical writers and/or external vendor/agencies. Implements tactical process improvements.


Qualifications

  • Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience. Advanced degree preferred.
  • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
  • 3 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, publications, clinical research, or product support/R&D.
  • 3 years experience in experimental design and clinical/preclinical data interpretation preferred.
  • Knowledgeable of US and international regulations, requirements and guidance associated with preparation of assigned writing projects.
  • Knowledge and experience working with templates and relevant systems
  • Excellent written and oral communication skills. Experience in working with collaborative, cross-functional teams, including project management experience.
  • Ability to assimilate and interpret scientific content and translate information for appropriate audience.
  • Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
  • Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No

Experience:

  • Mid-Senior level

Remote Job:

  • Yes

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 18, 2024
Company Overview
Randstad Life Sciences US
Randstad Life Sciences US

Current Openings: 0

Randstad North America, Inc. is a wholly-owned subsidiary of Randstad N.V., the world's largest HR services provider. Driven to become the world's most valued 'working life partner', supporting as many people as possible in realizing their true potential throughout their working life, we provide companies with the high quality, diverse, and agile workforces they need while helping people get rewarding jobs and stay relevant in the ever-changing world of work. In 2021, Randstad had on average 39,530 corporate employees and generated revenue of € 24.6 billion. Randstad's North American operations comprise 5,700+ associates and a deployed workforce of more than 86,000 in the U.S. and Canada. In addition to staffing and recruitment, Randstad offers outsourcing, consulting and workforce management solutions for generalist and specialist disciplines, including technology, engineering, accounting and finance, clinical and non-clinical healthcare, human resources, legal, life sciences, manufacturing and logistics, office and administration and sales and marketing. Global concepts available to North American client companies include RPO, MSP, integrated talent solutions, payrolling and independent contractor management and career transition services. Learn more at www.randstadusa.com or www.randstad.ca.
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