Regulatory Writing Manager, Biopharmaceutics - Remote; JP
Position: Regulatory Writing Manager, Biopharmaceutics - Remote (JP12795) 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:
- Must have experience briefing documents with significant clinical content/Module 2 clinical summary documents. Looking for 3-5 years of experience with these document types.
- Masters or higher degree in biology, chemistry, or other scientific field
- 5+ years in writing clinical and regulatory documents
- Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
- Ability to analyze medical data and interpret its significance
- Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
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:
- Masters or higher degree in biology, chemistry, or other scientific field
- 5+ years in writing clinical and regulatory documents
- Ability to optimally operate in an environment that involves negotiation, persuasion, collaboration, and analytical judgment
- Ability to analyze medical data and interpret its significance
- Sophisticated knowledge of scientific/technical writing and editing and of related regulatory guidance (eg, ICH) governing regulatory submission documents and industry compliance
- Strong written/oral communication skills and attention to detail
- Understanding and application of principles, concepts, theories, and standards of scientific/technical field
- Strong time and project management skills, engaging approach, and perseverance with a drive for results
- Leadership skills and ability to guide and influence the work of others
- Strong leadership in a collaborative team environment
Why is the Position Open? Supplement additional workload on team Interview Process: Phone screens and video conference We invite qualified candidates to sendyour resume 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 You are also welcome to sharethis opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr Apply tot his job Apply To this Job