Description

Pliant is seeking an accomplished, creative, and dedicated medical writer to contribute to the Company’s mission of bringing forth therapies for patients with life-threatening fibrotic diseases. The medical writer will be responsible for writing and overseeing the completion of various regulatory and clinical/nonclinical documents. This person will work in lockstep with the cross-functional teams to ensure the documents are of high quality, completed in a timely fashion, compliant with ICH/GCP/regulatory guidelines and aligned with company goals. The position will report to the Head of Regulatory Affairs and will oversee all the regulatory and clinical medical writing activities for Pliant’s development programs.

Responsibilities

• Oversees all medical writing deliverables for Pliant’s products including vendor oversight.
• Lead the development of regulatory documents in collaboration with the cross-function team (e.g. investigator brochures, INDs, eCTD clinical/nonclinical summaries, briefing books)
• Supports the document strategy discussions in collaboration with Regulatory Affairs
• Identify and manage priorities; assure the successful completion of high quality, timely and compliant document deliverables. Develop and implement remediation plans/actions as needed.
• Manages and mentors junior regulatory writing staff.
• Ensure smooth and effective document management from template to a final approved version, which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving)
• Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives as required.
• Distill clinical and scientific data into key messages to support regulatory documents.
• Develop templates and outlines for regulatory documents.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities and prior experience required.

• Bachelor’s degree in a scientific discipline required, advanced degree preferred.
• Minimum of 8 years of regulatory writing experience.
• Demonstrated experience in medical writing, editing, and clinical development.
• Familiar with eCTD structure, and experience with eCTD summary documents (e.g. Modules 2.5 and 2.7) and/or regulatory briefing document.
• Strong leadership, planning and project management skills, along with initiative and ability of be productive with minimal supervision and support.
• Excellent oral and written communication skills.
• Flexible and adaptive work style to meet organization needs.
• Working knowledge of FDA, EMA and ICH regulatory guidance and regulations.

Pliant requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).

The annual base salary for this role is $213,000 - $225,000. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.