Remote QC Medical Writer Consultant

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Job description

QC Medical Writer Consultant needs 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.
QC Medical Writer Consultant requires
Bachelors degree in a relevant scientific field is required.
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 Starting Point templates and AMA style.
Bachelors degree in a relevant scientific field is required
Covid-19 Vaccination Required
Oncology experience REQUIRED

QC Medical Writer Consultant duties:
Provide quality control (QC) review of clinical regulatory documents.
Collaborate with other members of the Medical Writing team to ensure that all QC findings are addressed as appropriate.
Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.
Assist in the development of templates and standard operating procedures (SOPs).
Assist in the production of high quality and on-time writing deliverables to support the activities and goals of the clinical study team(s), clinical program, and the Medical Writing function.