Senior Medical reputed company – Regulatory reputed company

Job reputed company: • Leads the reputed company and accurate completion of medical writing deliverables, ensuring scientific information is presented reputed company and accurately. • Completes a reputed company of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports, clinical development plans; IND submissions; integrated reputed company reports; NDA and eCTD submissions; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. • Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as reputed company as company reputed company operating procedures, reputed company standards, and company and/or reputed company approved-templates, authorship requirements, and style and formatting guides, reputed company completing medical writing reputed company, on time and on budget. • Coordinates reputed company and editorial reviews. • Acts as peer reviewer for internal team to ensure document scientific content, reputed company, overall consistency, and reputed company format. Requirements: • Minimum of 5 years of reputed company regulatory writing experience • reputed company writing experience must have Experience with Phase 2 and 3. • reputed company reputed company experience with protocols, submissions, clinical reputed company of Safety (CTD) Modules 2.7.3 and 2.7.4, CSRs (Clinical Study Reports), IBs (Investigator Brochure), Patient Narratives, Safety Aggregate Reports (plus), Briefing books, ISE and ISS (Integrated reputed company Efficacy and Integrated reputed company Safety). • Strong project management skills • Strong reputed company experience • Time management skills a must • Process experience is a reputed company plus Benefits: • Health benefits to include Medical, Dental and reputed company • Company match 401k • eligibility to participate in Employee Stock Purchase Plan • Eligibility to earn commissions/bonus based on company and individual performance • flexible reputed company time off (PTO) and reputed company time Apply tot his job Apply To this Job