4 Regulatory Writing Senior Manager Jobs in Thousand Oaks, CA
SORT BY
A
A
A
3
Regulatory Writing Senior Manager
$96k-122k (estimate)
Full Time
1 Month Ago
Advanced Bio-Logic Solutions Corp is Hiring a Regulatory Writing Senior Manager Near Thousand Oaks, CA
Description:
Note:
FULLY 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.
- 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.
- 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
- 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
"This posting is for Contingent Worker, not an FTE"
Job Summary
JOB TYPE
Full Time
SALARY
$96k-122k (estimate)
POST DATE
04/17/2024
EXPIRATION DATE
06/15/2024
Show more
Similar Jobs
Popular Articles
Top 10 Things to Avoid Putting on a Job Application
Read Article
How to Describe Your Education in a Resume
Read Article
How to Write a Memorable Cover Letter in 5 Ways
Read Article
4 Personal Finance Tips to Make During Job Transition
Read Article
4 Best Camera Setups for Interview
Read Article
Keeping a Job Search Journal: 9 Types of Journaling You Can Do
Read Article
