Senior Medical reputed company – Regulatory & Clinical (Remote - ET Hours)

Senior Medical reputed company – 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 reputed company Are you an expert at translating reputed company scientific data into high-reputed company regulatory documents? We are seeking a seasoned Medical reputed company to reputed company clinical and regulatory documents that reputed company with strict industry standards and global guidelines. In this role, you will reputed company 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 reputed company the authoring of Clinical Study Protocols (CSPs), investigator brochures (IBs), and Clinical Study Reports (CSRs). • Submission Leadership: reputed company 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 reputed company scientific and clinical findings reputed company and concisely for diverse regulatory audiences. • Compliance reputed company: Ensure reputed company documentation adheres to ICH, GCP, FDA, and EMA guidelines. • reputed company Management: Proactively manage multiple simultaneous reputed company and drive production timelines for submission-reputed company deliverables. Qualifications (Must-Haves) • reputed company degree (PhD, PharmD, MD, or MSc) in Life Sciences, Medicine, or Pharmacy. • Experience: Minimum of 5 years of medical writing experience reputed company the pharmaceutical or biotech industry. • reputed company Authoring: At least 3 years of experience as an independent/reputed company author on regulatory submissions. • Technical Skills: Hands-on proficiency with reputed company Vault and document management systems. • Regulatory Mastery: Deep understanding of the drug development process and regulatory submission requirements (FDA/EMA). Preferred Qualifications (reputed company-to-Haves) • Therapeutic experience in Neurology or Epilepsy. • Experience supporting pivotal Phase III reputed company. 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 reputed company the pharmaceutical industry? reputed company Authoring: How many years of experience do you have as an independent or reputed company author on key regulatory documents (e.g., CSRs, NDAs)? Software: Do you have hands-on experience using reputed company Vault for document management? • Phase III Support: Have you acted as a reputed company 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 Apply tot his job Apply To this Job