Medical Writing Consultant

Title: Medical Writer (Regulatory)

Location: REMOTE

Duration: 6 Months ongoing

W2 or 1099 available

35-40 hours a week

Position Summary:

The scope of this position includes the independently writing, document management, and development support for clinical study-related documentation including, but not limited to, clinical study protocols, Investigator's Brochures, and clinical study reports. The person will lead cross-functional teams to write and development regulatory submission documents, regulatory response documents, and other IND/CTA or global regulatory submission documents using internal SOPs.

Key Responsibilities:

• Provides Medical Writing leadership for one or more clinical programs.


• Acts as a medical writing subject matter expert and works with cross-functional team to deliver on medical writing program goals.


• Authors and manages the completion of clinical documents and other assigned tasks within established timelines with the highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.


• Drive document strategies and messages in a collaborative way with relevant project team subject matter experts.

Qualifications:

• Master’s or PhD in life or health science discipline in a relevant scientific field preferred.


• 5-8+ years of industry experience as a Medical Writer.


• Knowledge of clinical disclosure.


• Oncology experience a preferred


• Expert knowledge of standard clinical regulatory document types.


• NDA experience with active contribution in planning and preparation of summary documents is required.


• Excellent written communication skills, detailed oriented, self-directed and with the ability to be flexible and manage workload of multiple concurrent projects to meet project timelines.