Medical Writer

Medical Writer

Posted 1 week ago by 1751614092

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Negotiable
Outside
Remote
USA
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Document Management Document Management Systems Electronic Document Management Electronic Document Management Systems Electronic Documents Management Management Systems Microsoft Excel Microsoft Office Microsoft PowerPoint Stakeholder Management

Summary: The Medical Writer role involves creating and developing clinical documents to support global regulatory submissions within the pharmaceutical and biotechnology sectors. Candidates should possess a strong background in clinical research and demonstrate excellent communication and leadership skills. The position is remote and requires collaboration with various internal stakeholders. A minimum of 4-7 years of relevant experience is essential, along with a degree in Life Science.

Key Responsibilities:

  • Create and develop clinical documents for global regulatory submissions.
  • Interpret and organize scientific and clinical data.
  • Collaborate with internal customers across various levels of the organization.
  • Identify process improvements and manage change effectively.
  • Utilize electronic document management systems and content authoring technologies.

Key Skills:

  • Minimum of a BA/BS in Life Science; graduate degree preferred.
  • 4-7 years of pharmaceutical/biotechnology experience related to clinical research.
  • Expertise in writing clinical documents for regulatory submissions.
  • Excellent written and verbal communication skills.
  • Strong leadership and influencing skills.
  • Experience with ICH and electronic submission guidelines.
  • Proficient in MS Office and electronic document management systems.
  • Ability to function in an ambiguous environment.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: Other

Detailed Description From Employer:

Job Title: Medical Writer
Location: Remote
Duration: 12+ Months Contract
Tax Term: W2/C2C

Required:
Minimum of a BA/BS in Life Science; graduate degree preferred
4-7 years pharmaceutical/biotechnology experience related to clinical research
Demonstrated expertise in writing/developing clinical documents in support of global regulatory submissions
Ability to interpret and organize scientific and clinical data
Medical writing experience in Pharma, Biotech and/or CRO; medical device experience preferred
BA/BS + 7 years; MS/PhD + 4 years
Experience with ICH and electronic submission guidelines for regulatory reports.
Excellent written and verbal skills
Good leadership, communication, and influencing skills
Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
Ability to identify process improvements, manage change successfully, work with newer technologies, and foster an innovative atmosphere
Applies good judgment and demonstrates initiative to resolve issues
Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies preferred
Ability to function in an ambiguous environment

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