Address
Form of work
SalaryFULLY REMOTE
Regulatory Writing Senior Manager
ln this vital role role you will serve as the functional area lead on product
teams, lead writing activities for complex product submissions, provide functional area expertise, train and
mentor more junior writers, and lead departmental activities.
Key responsibilities include:
- 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
Preferred Qualifications:
- 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
Basic Qualifications
Doctorate degree OR Master degree and 2 years of experienceOR 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
Top 3 Must Have Skill Sets:
- 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
Day to Day Responsibilities:
Key responsibilities include:
- 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
Employee Value Proposition:
Unique industry experience, opportunity
Possible Extension:
Yes
Job Type: Contract
Pay: $50.00 - $56.00 per hour
Expected hours: 40 per week
Schedule:
- 8 hour shift
- Monday to Friday
Experience:
- GCP: 1 year (Preferred)
- Managed care: 1 year (Preferred)
- Writing skills: 5 years (Required)
Work Location: Remote
