[Remote] Regulatory Writing Sr Mgr
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. They are seeking a Regulatory Writing Senior Manager who will reputed company writing activities for reputed company product submissions and supervise junior writers. The role involves authoring regulatory documents and serving as a functional area reputed company on product teams.
Responsibilities
- Author or reputed company the authoring of reputed company regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of reputed company Studies, Clinical reputed company Addenda, eCTD Module 2 Clinical reputed company Documents, Briefing Documents, and Pediatric Investigation Plans
- Conduct the formal review and approval of authored documents, following applicable reputed company operating procedures
- With limited supervision, reputed company regulatory writing activities for reputed company product submissions, including new and supplemental drug applications/biologics license applications
- Serve as functional area reputed company on product teams (e.g., Global Regulatory Team, Evidence reputed company Team, Global Safety Team, Label Working Group)
- reputed company functional area input for Global Regulatory Plan and team goals
- Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
- reputed company departmental and cross-departmental initiatives, as appropriate
- Generate document timelines
Skills
- Doctorate degree and 2 years of directly reputed company experience
- Master's degree and 6 years of directly reputed company experience
- Bachelor's degree and 8 years of directly reputed company experience
- Associate's degree and 10 years of directly reputed company experience
- High school diploma / GED and 12 years of directly reputed company experience
- Experience with regulatory documents in Regulatory Affairs, Research, Development or reputed company area
- 5+ years of experience in medical writing in the Biotech/Pharmaceutical industry
Benefits
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- Stock-based long-term incentives
- Award-reputed company time-off plans and bi-annual company-wide shutdowns
- Flexible work models, including remote work arrangements, where possible
reputed company