Job Description

Job details

Senior Medical Writer
Kelly Science and Clinical is seeking a Senior Medical Writer for our client a leading Pharmaceutical company in Bridgewater, NJ. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust the experts hiring experts



Schedule : Remote with occasional travel to Bridgewater, NJ
Monday through Friday day shift

Length of assignment: two years

Pay $60 - $75 an hour with flexibility



Responsibilities

• Author key documents, ensure quality review, and adhere to timelines for critical deliverables.
  
  
  
  
• Prepare documents including, but not limited to:
  
  
  
  
• Clinical study reports
  
  
  
  
• Marketing application summaries
  
  
  
  
• Health authority meeting briefing documents
  
  
  
  
• Other integrated data summary reports
  
  
  
  
• Contribute medical writing expertise to Project and Submission teams for report preparation and production of registration dossiers.
  
  
  
  
• Ensure a consistent presentation style for clinical documents to maintain quality and ease of review, adhering to company standards.
  
  
  
  
• Work effectively with the company's document management system, tools, templates, and procedures to ensure efficient document and dossier publishing.
  
  
  
  
• Ensure medical writing activities meet quality standards, expectations, and adhere to applicable corporate SOPs, Work Practices, policies, guidelines, and regulations.
  
  
  
  
• Stay current on ICH, FDA, EMA, and Health Canada guidelines regarding medical writing.

Qualifications/Training:

• A scientific degree in life sciences is required.
  
  
  
  
• Knowledge and experience with pharmaceutical development processes, including preparation of documents for marketing applications, responses, and meetings.
  
  
  
  
• Experience:
  
  
  
  
• Previous experience as a Medical Writer ideally 5 years plus
  
  
  
  
• Understanding of basic statistics, pharmaceutical safety, and investigational research.
  
  
  
  
• Excellent oral and written English skills.
  
  
  
  
• Technical proficiency with electronic document management and word processing software, particularly strong Microsoft Word skills.
  
  
  
  
• Ability to work autonomously and proactively.
  
  
  
  
• Possesses a sense of urgency and is deadline-oriented.
  
  
  
  
• Works in an accurate, meticulous manner; is detail-oriented.
  
  
  
  
• Displays a solid work ethic, professionalism, organizational ability, and follow-up skills.

What happens next
Once you apply, you'll proceed to the next steps if your skills and experience look like a good fit. But don't worry-even if this position doesn't work out, you're still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what's next in your career is what we're all about,
#P1

9762446 Kelly Services

Job Tags

Day shift, Monday to Friday,

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