Safety Project Manager

at Certara USA, LLC in Wilmington, Delaware, United States

Job Description

At Certara, we accelerate medicines to patients by partnering with life science innovators.

In the past 6 years, over 90% of companies that received new drug approvals by the FDA used our software or services. Our integrated and proprietary end-to-end platform with biosimulation, regulatory science, and market access solutions combined with our strong team of scientists and subject matter experts enable our clients to have:

informed decision-making & reduced clinical trial burden

higher R&D productivity

improved patient outcomes & increased patient access to medicines

accelerated regulatory approval

Certara is a global team that fosters and nurtures a diverse and inclusive culture. We are proud to be an Equal Opportunity Employer. The collective sum of our individual differences, life experiences, knowledge, innovation, self-expression, and unique capabilities and talent represents a significant part of our culture, our reputation and our achievement.

Together with our partners, we use biosimulation and technology-enabled services to transform drug discovery and development across all therapeutic areas and innovative therapies.

Synchrogenix, a Certara Company: Achieving Regulatory Success

As Certara's Regulatory Science division, Synchrogenix accelerates the regulatory submissions of medical innovations worldwide through customized regulatory solutions, including strategy, communications, operations and technology. Synchrogenix is comprised of some of the most respected talent in the industry, including thought leaders, writers and editors, and regulatory submissions specialists. Our people are talented, quality-minded, and client and stakeholder-oriented.

Synchrogenix's people are at the core of our success, and our most successful people are:

collaborative and value being part of a team

experts with a thirst for continued learning

consultative with an ability to articulate process and expertise

deadline-driven and able to operate in a fast-paced environment


Job Overview:

The Safety Project Manager (SPM) works together with the narrative project leads, regulatory safety and narrative writers, and editors interfacing directly with the client as needed, to provide project management support for the department's safety and narrative projects. The SPM liaises with the internal resourcing team to ensure the appropriate assignment of authors, editors, and subject matter experts per project and client.


Conduct Project Management activities to deliver quality, efficiency, and timely solutions to clients

Plan, develop, monitor, and track project schedules through an integrated project management system across clients and concurrent projects

Manage budget and deliverables timelines throughout the project lifecycle

Manage the departmental project portfolio to meet evolving deadlines by balancing and optimizing resources

Implement a scope change and communication process to inform all stakeholders of the related impact on time and budget

Support the Client/Project Lead in all aspects of project management activities such as time, resource and budget tracking, project planning and reporting, as well as client interactions

May support data transfer, meeting planning, and meeting management

Perform cross-functionally by supporting and interacting with narrative writing teams, business development representatives, and the narrative and safety project leads depending on organizational needs and priorities

Develop and distribute daily, weekly, and/or monthly reporting metrics, as needed

Act as a client advisor, working with all parties to lead the development of strategies for organizing and preparing narratives and safety deliverables

Practice creative and blameless problem solving, taking the department's goals and a broad perspective to resolve issues to prevent negative impact to work

Usher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus on behalf of project leads, as needed

Maintain collaborative, proactive, and effective communication with both client and internal teams

Lead or participate in project-related meetings and teleconferences, as needed

Education, Experience, Training, and Knowledge:

Bachelor's degree in health sciences or other directly related field

Minimum of 5 years of experience in a project management role in either pharmaceutical, biotech, or contract research organization(s) in positions of increasing responsibility

Patient narrative writing... For full info follow application link.


Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.        


Copy Link

Job Posting: 862783

Posted On: Oct 25, 2021

Updated On: Nov 20, 2021