QC Medical Writer

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Job description

Description:

Medical writing deliverables that support SDP Oncology's clinical oncology portfolio are subject to Quality Control (QC) audits. As needed, the QC Medical Writer will help in the preparation of basic to moderately complex clinical research papers (such as clinical study protocols/amendments, portions of clinical study reports, and safety narratives).

KEY RESPONSIBILITIES:

• Review clinical regulatory documentation for quality control (QC).


• Work with other members of the Medical Writing team to ensure that any QC findings are properly addressed.


• Maintain a consistent style of clinical document presentation to ensure quality and simplicity of review, as well as conformance to business standards.


• Contribute to the creation of templates and standard operating procedures (SOPs).


• Assist in the development of high-quality, on-time writing deliverables to support the clinical research team(s), clinical program, and Medical Writing function's activities and goals.

Oncology experience REQUIRED

THIS IS A REMOTE ROLE

Skills:

• Bachelor's degree in a relevant scientific field is required.


• A minimum of 2 years of document quality control experience in the biopharmaceutical industry with a working knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.


• Strong written and verbal communication skills, including fluency in oral and written English, with the ability to interpret data sufficiently to allow confirmation of associated text descriptions.


• High attention to detail and an ability to retain focus over an extended period of time.


• Experience with StartingPoint templates and AMA style.

Education:

• Bachelor's degree in a relevant scientific field is required


• Covid-19 Vaccination Required

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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