Senior Medical Writer

Job Summary

Title: Senior Medical Writer

Company: Pharma / Biotech Company

Location: Philadelphia, PA

Type: Permanent Role

Notes: No Corp to Corp

Responsibilities:

• Draft, edit, format, and finalize documents including, but not limited to: clinical protocols and amendments, investigator's brochures (IBs), clinical study reports (CSRs) and development safety updatereports (DSURs).
• Provide quality control (QC) review of clinical and regulatory documents including data output.
• Produce high quality and on-time writing deliverables ensuring scientific consistency between related documents or studies in a clinical program.
• Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.
• Facilitate efficient review and finalization process of documents produced internally and externally by contractors and vendors.
• Assisting in the development of templates and standard operating procedures (SOPs).
• Representing Medical Writing on one or more programs

Requirements:

• Advanced degree (MS or PhD) in a relevant scientific field.
• A minimum of 3 years medical writing experience in a pharma, biotech, or a combination of CRO and pharmaceutical setting with in-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
• Strong written and verbal communication skills, with the ability to clearly present clinical data.
• Regulatory submissions and knowledge of eCTD formatting preferred.
• Oncology experiencepreferred.

Contacts: APPLY TODAY and one of our recruiters will reach out to you shortly.

Referral Bonus: As always, we will give you a referral bonus if we place someone you refer over to us! Ask for details.