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Job Details

Senior Regulatory Writer

Company name
Synchrogenix

Location
Thousand Oaks, CA

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Profile

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:

Synchrogenix, 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. Synchrogenix has two wholly owned subsidiaries: Synchrogenix Europe Limited, headquartered in Daresbury, UK, with an additional office in London; and Synchrogenix Philippines Inc. (SPI), headquartered in Manila.

Founded in 1986, Synchrogenix takes a unique team approach to projects drawing from the varied skills and backgrounds of its writers and editors. This approach enables Synchrogenix to bridge all functional areas within drug development, with the singular focus on regulatory/medical documentation. Regulatory writing is truly an expertise, and Synchrogenix’s 150 permanent writers and editors are among the best in the world.

Synchrogenix 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 Synchrogenix the consultancy of choice for life science and biotechnology companies worldwide. Synchrogenix 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:

Synchrogenix 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. Synchrogenix 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)

Company info

Synchrogenix
Website : http://www.synchrogenix.com/

Company Profile

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