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