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Medical Writer 🔥


A pharmaceutical company in New Jersey is looking to add a new Medical Writer to their Global Regulatory Affairs Department in a Remote capacity. In this role, the Medical Writer (Remote) will be responsible for ensuring communications are complete, well organized & scientifically accurate, and that messaging is consistent throughout all technical documentation.

Responsibilities:

The Medical Writer (Remote) will:

  • Proactively manage writing activities across assigned projects; ensure adherence to the medical writing strategy and alignment with business needs
  • Contribute to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents
  • Author deliverables with consideration for regulatory, corporate, departmental, and quality standards
  • Adhere to medical writing practices/systems / tools to support clinical studies in order to meet company goals and objectives
  • Assure that standardized practices are implemented and maintained across all therapeutic areas
  • Engage with team members to ensure medical writing continues to deliver value to the business
  • Ensure medical writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations
  • Support innovation initiatives within the Medical Writing Group
  • Perform other duties, as needed

Qualifications:

  • 4+ years of related Clinical Research experience in a Biotechnology / Pharmaceutical setting
  • Bachelor's Degree in Life Sciences and/or related field
  • Demonstrated expertise in writing / developing clinical documents in support of Global Regulatory Submissions
  • Ability to interpret and organize Scientific and Clinical Data
  • Experience with ICH and electronic submission guidelines for regulatory reports
  • Computer savvy
  • Microsoft Office Suite proficient (Excel, Outlook PowerPoint, Word, etc.)
  • Solid problem solving and time management skills
  • Great interpersonal skills
  • Excellent communicaiton skills (written and verbal)
  • Strong attention to detail
  • Highly organized

Desired Skills:

  • Graduate Degree
  • Medical Device background
  • Experience with Electronic Document Management systems and other Content Authoring technologies
  • Ability to work EST hours

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