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Regulatory Program Manager

Company: Certara
Location: Wilmington
Posted on: August 16, 2019

Job Description:

Position: Regulatory Program Manager

Location: Wilmington, DE; Philadelphia, PA; Remote

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.

Job Summary

The Regulatory Program Manager collaborates with the regulatory and submission leads for our regulatory consultation, document writing and submission level services. This individual manage regulatory projects across multiple clients and work with internal project groups to advance agreed upon deliverables within budget and timelines. have the capability of tracking milestones as well as helping the clients and client leads navigate the global landscape.

Responsibilities

* Advisory role for regulatory and submission leads for Synchrogenix programs with clients for which we perform regulatory consultation and services

* Ability to run/manage cross functional meetings with teams and individual team members to discuss activities, actions, timelines and risks.

* Develop and maintain project plans (includes Narratives, CSRs, IBs, CMC, Drug Safety, and other workstreams within our services division)

* Create and maintain timelines for simple and complex programs, identify dependencies and monitor/escalate as appropriate

* Track all deliverables on multiple projects to schedule and budget, identify out of scope activities and client expansion opportunities, support services and sales in scoping discussions

* Coordinate internal staff, vendors and client expectations and activities towards successful completion of projects and programs on time and on budget (change orders, etc)

* Assist in tracking of KPIs related to program specific client and employee experiences

* Manage meetings, e-mails, and resourcing of regulatory cover letters and forms in support of client programs

* Bridge communications between sales, services delivery, and clients

* Participate, and in some cases lead, interactions and meetings with clients and/or health authorities [ Lead and participate in client interactions, meetings and project planning]

* Liaise with project coordination to ensure accurate timeline, budget updates to Finance

Required Qualifications

* Bachelor s degree

* Skilled at working with large, diverse teams

* Experienced project/program manager, familiar with Excel, MS Project, and other timeline and tracking tools

* Implementation of Project Management Frameworks

* Clear and concise communicator, detail and process oriented

* Project Management within the Life Sciences Industry

Preferred Qualifications

* Extensive knowledge of drug development and regulatory requirements and submissions process (US and other countries/regions)

* Familiarity with regulatory publishing process (both document-level and submission publishing)

* PMP / PRINCE II or other project management certifications

* Lean Six Sigma experience a plus

* Must have taken a project from a sponsor through final approval

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, Wilmington , Regulatory Program Manager, Executive , Wilmington, Delaware

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