3key Consulting, Inc. is hiring : Regulatory Writing Manager, Biopharmaceutics -

Job Title : Regulatory Writing Manager, Biopharmaceutics - Remote (JP12795)

Location : Thousand Oaks, CA. 91320 (REMOTE)

Business Unit : Global Regulatory Affairs Execution Team

Employment Type : Contract

Duration : 6+ months (with possible extensions)

Rate : $46 - $50 / hr. W2.

Posting Date : 6 / 27 / 2024.

Notes : Only qualified candidates need apply. Fully remote. Approximately 30 hours per week.

3 Key Consulting is hiring! We are recruiting an Regulatory Writing Manager for a consulting engagement with our direct client, a leading global biotechnology company.

Job Description :

In this vital role you will prepare and coordinate the preparation of regulatory submission documents that comply with global regulatory standards. Day to day activities include :

• Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4)
• Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of All Studies, briefing documents, and safety narratives
• Write other regulatory submission documents (eg, RTQs, PIPs, white papers, breakthrough therapy applications, orphan drug applications)
• Lead study timelines for regulatory documents and regulatory submission strategy
• Act as a functional area representative and lead on product teams
• Assist with the following activities : hiring, resourcing therapeutic areas and project teams, and departmental governance
• Ensure quality of regulatory submission documents at all stages of development
• Provide expertise and mentorship on document design and principles of good medical writing to the department and product teams
• Participate in departmental meetings, as well as departmental and cross-departmental initiatives

Top Must Have Skill Sets :

Basic Qualifications :

Doctorate degree

Or

Master’s degree and 3 years of Writing Regulatory or scientific submission / documents experience

Or

Bachelor’s degree and 5 years of Writing Regulatory or scientific submission / documents experience

Or

Associate’s degree and 10 years of Writing Regulatory or scientific submission / documents experience

Or

High school diploma / GED and 12 years of Writing Regulatory or scientific submission / documents experience

Preferred Qualifications :

Why is the Position Open?

Supplement additional workload on team

Interview Process :

Phone screens and video conference

We invite qualified candidates to sendyour resume to resumes@3keyconsulting.com . Ifyou decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com / careers. You are also welcome to sharethis opportunity withanyone you think might be interested in applying for this role.

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