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Job Details

Senior Regulatory Writer

Location
Thousand Oaks, CA

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Responsibilities
Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer, depending on document type or therapeutic experience
Author documents per client specifications, templates, style guides, and other guidance documents
Author documents per regulatory authority guidelines and requirements
Act as a client point of contact
Manage budget for respective project or task within a project
Usher documents through the review process, conduct comment resolutions meetings (CRMs)
Maintain collaborative, proactive, and effective communication with both client and internal teams
Lead or participate in project-related meetings and teleconferences
Experience Required
Experience writing study-level documents in their entirety and the ability to lead/own a study-level document
Collective experience writing a range of study-level documents for various clients: Investigator's Brochure
Protocol
Clinical Study Report - abbreviated and synoptic
Pharmacokinetic Reports
QT Studies
Observational and Non-interventional Reports
Experience in the development of submission-level documents (does not require functioning as a document lead): Briefing Packages
IND/CTA/IMPD
NDA/BLA/MAA/NDS
Skill Requirements
BS/BA
3-5 years of regulatory writing experience with nonclinical, clinical, CMC, or drug safety related documentation
Strong understanding of the document creation process and of clinical development and study level clinical operations from conceptual study design to final CSR/CTR
Ability to analyze clinical data and present it in a written format
Ability to conduct/lead a CRM and successfully lead a project team to consensus
Ability to provide high-quality customer service and follow-through on all assignments
Excellent Microsoft Word skills and document management techniques
Professional, personable demeanor
Strong interest in a writing/editing role
The Ideal Candidate
Is a team player who enjoys collaboration
Desires challenges, both technical and interpersonal
Is flexible with an extremely high level of attention to detail
Desires challenges, both technical and interpersonal
Opportunity and Value for the Right Candidate
Variety— submission-level work across therapeutic areas
Flexibility — custom schedules and benefits of “flex time”
Stability — almost 30 years in business
Support — a community of writers working as a team
Excellent potential for growth and advancement
Company Description
Company Overview:
**MEMBERS ONLY**SIGN UP NOW***., a Certara® company, is a global, multimillion-dollar regulatory and scientific writing company headquartered in Wilmington, DE, with US offices in Atlanta, GA; Thousand Oaks, CA; Cincinnati, OH; Philadelphia, PA; Raleigh, NC; Malvern, PA; Parsippany, NJ; San Diego, CA; Nashville, TN; Orlando, FL; Gaithersburg, MD; and Cambridge, MA. **MEMBERS ONLY**SIGN UP NOW***. has two wholly owned subsidiaries: **MEMBERS ONLY**SIGN UP NOW***. Europe Limited, headquartered in Daresbury, UK, with an additional office in London; and **MEMBERS ONLY**SIGN UP NOW***. Philippines Inc. (SPI), headquartered in Manila.
Founded in 1986, **MEMBERS ONLY**SIGN UP NOW***. takes a unique team approach to projects drawing from the varied skills and backgrounds of its writers and editors. This approach enables **MEMBERS ONLY**SIGN UP NOW***. to bridge all functional areas within drug development, with the singular focus on regulatory/medical documentation. Regulatory writing is truly an expertise, and **MEMBERS ONLY**SIGN UP NOW***.’s 150 permanent writers and editors are among the best in the world.
**MEMBERS ONLY**SIGN UP NOW***. now offers additional technologies and services that expedite the regulatory process. These include:
• The only artificial intelligence assisted medical writing service in the pharmaceutical industry. This transformative technology helps clients to better meet global transparency and disclosure requirements.
• Submission Management - our suite of products consists of the solutions regulatory operations professionals need to efficiently manage and publish, validate and review eCTD submissions.
• Regulatory Services - submission and publishing services for marketing and pre-marketing applications as well as subsequent lifecycle submissions to support original applications.
• Document Management - an intuitive, affordable document management system that reduces complexity form a user perspective while meeting the same robust standards for security and regulatory compliance
This combined knowledge makes **MEMBERS ONLY**SIGN UP NOW***. the consultancy of choice for life science and biotechnology companies worldwide. **MEMBERS ONLY**SIGN UP NOW***. was named one of the INC 500/5000 Fastest Growing US Companies in 2012, 2013, 2014, 2016 and 2017 has been named a Best Place to Work multiple times.
Corporate Culture:
**MEMBERS ONLY**SIGN UP NOW***. was founded on the principles of ethical business practices and high-quality work. It is a learning-oriented organization with a strong commitment to the idea that every individual—regardless of experience level—has something to teach and something to learn. **MEMBERS ONLY**SIGN UP NOW***. has built its culture on:
• Being fast and flexible, non-hierarchical, apolitical, and non-defensive
• Active participation—nobody sits on the sidelines
• Teamwork—the company’s success is important to all of us
• Cross-functional communication (lots of it) and a high-tech culture that works to have everyone on the same page
• Disciplined leadership that inspires passion and commitment
• Personal accountability
• Strong peer and management support for those who want to learn
Location/Region: Thousand Oaks, CA (US)
Posted on
ZipRecruiter Jobs
2018-07-12

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