HendersonvilleRecruiter Since 2001
the smart solution for Hendersonville jobs

Principal Regulatory Writer - US Locations

Company: Certara
Location: Nashville
Posted on: October 21, 2019

Job Description:

Position: Principal Regulatory Writer
Location: US Locations

Company Overview: Regulatory and Communications Strategy, Science, and Solutions

As the largest consultancy of regulatory and medical writers in the industry, Synchrogenix is already a well-recognized, multi-disciplined provider of regulatory writing, operations, and communications services. Additionally, our innovative technology platform, which includes both the ClinGenuity Artificial Intelligence (A.I.) engine and the GlobalSubmit portfolio of electronic common technical document (eCTD) and regulatory information management (RIM) software, brings a unique end-to-end solution to our clients with the capability to transform the way we plan, create, deliver, and access and track information all of which is essential to empowering decision-making for various stakeholders who are invested in healthcare research and innovation.

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 expertise has something to teach and something to learn.

Our Mission

Providing regulatory and communications strategy, science, and solutions to life science companies worldwide. Our regulatory expertise and innovative technology bridges the full regulatory continuum to propel treatments to the market by meeting the needs of all stakeholders and improving public health outcomes.

Our Vision

To revolutionize global healthcare by delivering transformative and innovative approaches to regulatory and communications strategy, science, and solutions. To build next generation talent, solutions and technology that remove barriers and create efficient pathways to treatment and information. We provide expertise in:

* Regulatory Intelligence, Policy & Strategy

* Synchrogenix s Office of Regulatory Intelligence, Policy and Strategy is comprised of proactive policy drivers focused on efficient planning who provide real-time regulatory insights to guide sponsors through the global regulatory maze by making connections with new precedents and trends to influence outcomes and maximize success.

* Regulatory Communications

* Quality information handling is vital throughout a drug s lifecycle. Synchrogenix provides distinct market offerings that advance and protect ownership, yet support collaboration through customer engagement and transparency.

* Regulatory Operations

* Synchrogenix ensures efficient, timely submissions through software and services solutions that break down barriers between strategy, dossier development and global transmissions. Through experience, expertise, and industry insight, Synchrogenix quickly responds to changes in global regulatory requirements and mandates, thus avoiding common issues that can lead to rejections.

* Global Stakeholder Communications

* Synchrogenix provides expertise and relevant communications to global audiences through services and innovative technology. Our offerings support our clients regulatory compliance, while reducing risk and enhancing potential for market success. These offerings include, but are not limited to: regulatory writing, medical communications, safety/pharmacovigilance, patient engagement, and transparency and disclosure.

* Technology & Innovation

* Synchrogenix delivers interoperable and innovative technologies that support our services and differentiate ourselves in the market. Additionally, Synchrogenix provides strategy and delivery capabilities to implement emerging technology solutions both internally and externally.

Work closely with client, internal, and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
Lead a project team comprised of internal and client team members as well as partner organizations
Serve as a liaison and subject-matter expert for clients, guiding and advising them on strategies and best practices for achieving approval from regulatory authorities
Author documents per client specifications, templates, style guides, and other guidance documents
Author documents per regulatory authority guidelines and requirements
Manage overall budget for respective project, including all contributing writers and editors
Usher documents through the review process, conduct comment resolutions meetings (CRMs)
Maintain collaborative, proactive, and effective communication with both client and internal teams
Lead project-related meetings and teleconferences
Provide training of writing staff and ensure compliance with company standard operating procedures (SOPs) and staff training requirements.

BA/BS (minimum)
Preferred but not required - 10+ years of regulatory writing experience with nonclinical, clinical, CMC, or drug safety related documentation
Shown success in Word skills and document management techniques
Collective experience writing a range of study-level documents in their entirety and able to lead/own a study level document
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
Professional, personable demeanor
Strong interest in a writing/editing role

Synchrogenix is proud to be an Equal Opportunity Employer and will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status, or any other characteristic protected by law. Synchrogenix makes reasonable accommodations for disabled employees and applicants. Synchrogenix only employs individuals with the right to work in the country/ies where the role is advertised. We are committed to fostering, cultivating, and preserving a culture of diversity and inclusion. The collective sum of the individual differences, life experiences, knowledge, inventiveness, innovation, self-expression, unique capabilities and talent that our employees invest in their work represents a significant part of not only our culture, but our reputation and achievement.

Keywords: Certara, Hendersonville , Principal Regulatory Writer - US Locations, Advertising , Nashville, Tennessee

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Advertising Jobs

Digital Media Sales Representative
Description: Our team is growing and we are looking for energetic Digital Media Sales Representatives. You will be a key member of a growing team focused on the execution of innovative digital advertising campaigns (more...)
Company: Vivial
Location: Nashville
Posted on: 11/13/2019

Digital Content Editor
Description: This exciting position -is the perfect blend of an entry level producer/editor. -Expect to edit some amazing content as we prepare to launch our linear tv and
Company: Circle (Gray TV and Ryman Hospitality Joint Ventur
Location: Nashville
Posted on: 11/20/2019

Senior Manager of Digital & Search Media
Description: US-TN-NashvilleJob ID: 2019-6968Category: MarketingJob Type br br Full-Time br br Overview br br We're SmileDirectClub, and we believe everyone deserves a smile they'll love. We also believe (more...)
Company: SmileDirectClub
Location: Nashville
Posted on: 11/17/2019

Nashville Associate Editor
Description: StyleBlueprint Nashville Associate Editor Job Description: -StyleBlueprint Nashville is hiring for a full-time associate editor position. This position requires a positive attitude, a curiosity about (more...)
Company: StyleBlueprint
Location: Nashville
Posted on: 11/13/2019

Senior Manager Digital Marketing
Description: The Senior Manager - C4 Digital Marketing is primarily responsible for servicing one solution for one client varies by team by focusing on renewing current contracts, helping to develop new business (more...)
Company: Urban Science
Location: Nashville
Posted on: 11/15/2019

Entry Level Marketing Representative
Description: Our team-oriented environment and high standards for excellence are conducive to unlimited professional and personal growth. br br Here are some qualifications you, our ideal candidate, should possess: (more...)
Company: ProTenn
Location: Nashville
Posted on: 11/14/2019

Email Marketing Processor
Description: Email Marketing Processor Mommy Jobs Online is needing remote contractors that is able to send out our daily email marketing campaigns. This is a fun, busy and easy job with a career advancement and growth (more...)
Company: mommyjobs llc
Location: Nashville
Posted on: 11/19/2019

Marketing Coordinator
Description: Review the Job Description, Requirements, and duties then follow the link below to complete the application process: br Applicants who do not follow this link and complete the assessment WILL NOT BE (more...)
Company: The Property Management Connection, LLC
Location: Nashville
Posted on: 11/19/2019

MAC Artist - 18hrs - Murfreesboro, TN
Description: MAC Artist - 18hrs - Murfreesboro, TN Brand: MAC Description Position Summary: As one of our highly skilled make-up artists you will combine your creative and technical expertise and passion for people (more...)
Company: Clinique
Location: Murfreesboro
Posted on: 11/15/2019

Photographer - Graduation Events - Nashville, TN
Description: GradImages is currently searching for photographers to work with us during graduation events in Nashville, TN and around the surrounding area. Do you have photography experience using a DSLR camera Are (more...)
Company: Iconic Group
Location: Clarksville
Posted on: 11/20/2019

Log In or Create An Account

Get the latest Tennessee jobs by following @recnetTN on Twitter!

Hendersonville RSS job feeds