Lead Medical Writer

Lead Medical Writer

Boston, Massachusetts - United States

Summary:

Seeking an experienced Lead Regulatory Writer for a designated therapeutic area program(s) to support critical regulatory medical writing needs while offering direction and support to other staff, vendors, and contractors regarding these projects. As the Lead Writer expectations to mentor staff to ensure quality and efficacy in the production of clinical regulatory documents. You'd have the opportunity to work with a top pharmaceutical company in the leading of the development and approvals of all clinical regulatory document types. As the Lead Writer, you'd ensure timely completion, accuracy, and quality of all clinical submission documentation across all aspects of lifecycle management. This Lead will be expected to provide scientific writing guidance, submission preparation, regulatory guidance and technical expertise in the generation of the writing, production, and review of high quality regulatory and other scientific/clinical documents in compliance with regulatory guidelines.

Skills & Competencies:

• Leadership and mentoring skills
• Strong oral and written communication skills
• Strong analytical and organizational skills
• Excellent project management skills with proven track record of meeting clinical timelines
• Demonstrated success to lead the development, review, and approval of all clinical regulatory documents, i.e.: IBs, study protocols and amendments, study reports, clinical/integrated summaries, clinical overviews, contributions to briefing documents, response documents, and IND/CTA or global regulatory submission documents

• Strong knowledge of current global regulatory requirements and guidelines; GCP, ICH, eCTD compliant documents
• Experience with understanding and employing global regulatory authorities' regulations and guidance, i.e.: CSRs, IBs, ICH: E3/E6/M4/E2E

Requirements:

• Advanced degree (PhD) in a relevant discipline is highly preferred; Master's degree is required

• 8-10+ years of experience in clinical/pharmaceutical development with 8+ years directly related scientific/clinical regulatory writing experience
• Global regulatory submission experience required
• Diverse experience across different therapeutic areas, i.e.: Oncology, Neuroscience, CNS, etc.
• **This is a permanent position located in Massachusetts. Role has some flexibility with the schedule; however, an on-site presence is required.

If interested in learning more, please contact Bria Gaber at bria.gaber@investigo-us.com or (646) 430-1191 for more information.