Senior Medical Writer – Regulatory & Clinical (Remote - ET Hours)Location: Remote (Must support Eastern Time Zone hours) Job Type: Full-time, Contract (Initial term through August with extension potential) Industry: PharmaceuticalsJob Overview Are you an expert at translating complex scientific data into high-quality regulatory documents? We are seeking a seasoned Medical Writer to develop clinical and regulatory documents that comply with strict industry standards and global guidelines. In this role, you will lead the authoring of critical Phase III study documents and collaborate with cross-functional teams (Clinical, Regulatory, Biostatistics) to drive successful submissions.Key Responsibilities
• Regulatory Authoring: Prepare and lead the authoring of Clinical Study Protocols (CSPs), investigator brochures (IBs), and Clinical Study Reports (CSRs).
• Submission Leadership: Develop Common Technical Document (CTD) Modules (2.5 & 2.7) and support New Drug Applications (NDAs), Biologics License Applications (BLAs), and Marketing Authorization Applications (MAAs).
• Data Interpretation: Simplify and communicate complex scientific and clinical findings clearly and concisely for diverse regulatory audiences.
• Compliance Oversight: Ensure all documentation adheres to ICH, GCP, FDA, and EMA guidelines.
• Timeline Management: Proactively manage multiple simultaneous projects and drive production timelines for submission-ready deliverables.
Qualifications (Must-Haves)
• Education: Advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, or Pharmacy.
• Experience: Minimum of 5 years of medical writing experience within the pharmaceutical or biotech industry.
• Lead Authoring: At least 3 years of experience as an independent/lead author on regulatory submissions.
• Technical Skills: Hands-on proficiency with Veeva Vault and document management systems.
• Regulatory Mastery: Deep understanding of the drug development process and regulatory submission requirements (FDA/EMA).
Preferred Qualifications (Nice-to-Haves)
• Therapeutic experience in Neurology or Epilepsy.
• Experience supporting pivotal Phase III clinical trials.
Pay: $80.00 per hour
Application Question(s):
• Education: Do you hold an advanced degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, or Pharmacy?
Experience: Do you have at least 5 years of medical writing experience specifically within the pharmaceutical industry?
Lead Authoring: How many years of experience do you have as an independent or lead author on key regulatory documents (e.g., CSRs, NDAs)?
Software: Do you have hands-on experience using Veeva Vault for document management?
• Phase III Support: Have you acted as a lead author for Phase III clinical study reports?
Time Zone: This role is remote but requires supporting Eastern Time (ET) working hours. Can you meet this requirement?
Work Location: Remote