70 applicants
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Aditi Consulting ยท 2 days ago
Regulatory Writing Senior Manager
United States
Contract
Remote
Mid, Senior Level
5+ years exp
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Hiring Manager
RUPALIM DUTTA
Insider Connection @Aditi Consulting
Responsibilities
Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide 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
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines
Qualification
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Required
Doctorate degree OR Master degree and 2 years of experience OR Bachelor degree and 4 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
Experience leading writing activities for new or supplemental drug applications/biologics license applications is strongly preferred
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+years of experience in medical writing in the Biotech/Pharmaceutical industry
Preferred
Experience leading writing activities for new or supplemental drug applications/biologics license applications is strongly preferred
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+years of experience in medical writing in the Biotech/Pharmaceutical industry
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
1,001-5,000 employees
H1B Sponsorship
Aditi Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (24)
2022 (22)
2021 (27)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Raja Narayana
President & CEO
Pradeep Singh
Chairman
Recent News
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