Medical Writer
Posted 2 weeks ago by 1752644990
Negotiable
Outside
Remote
USA
Summary: The Medical Writer role involves developing clinical documents to support global regulatory submissions within the pharmaceutical and biotechnology sectors. Candidates should possess significant experience in clinical research and demonstrate strong writing and communication skills. The position is remote and requires collaboration with various internal stakeholders. A background in life sciences and familiarity with regulatory guidelines is essential for success in this role.
Key Responsibilities:
- Develop and write clinical documents for global regulatory submissions.
- Interpret and organize scientific and clinical data effectively.
- Collaborate with internal customers across various levels of the organization.
- Identify process improvements and manage change successfully.
- 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.
- Ability to work in an ambiguous environment.
- Proficient in MS Office and electronic document management systems.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Job Title: Medical Writer
Location: Remote
Duration: 12+ Months Contract
Experience: 10 Years
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