Regulatory Safety Project Manager

Overview:

About Certara

Our portfolio spans the discovery, preclinical, clinical and post-marketing phases of drug development, working with 1,200 commercial companies, 250 academic institutions, and numerous regulatory agencies.

The SPM liaises with the internal resourcing team to ensure the appropriate assignment of authors, editors, and subject matter experts per project and client.

Responsibilities:

• 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

Qualifications:

• 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 experience required to allow anticipation of the effects that writing practice conventions may have when seeking health authority approval/acceptance
• Knowledge of project tracking and accounting software, Mavenlink and Smartsheet is preferred but not essential
• Hands-on experience in scoping and executing complex projects
• Possesses a working knowledge of major regulatory authority guidelines and requirements (US, EU, and Canada preferred) enabling proactive identification and mitigation of hurdles and compliance issues
• Intermediate proficiency with Microsoft Word (editing tools, creating and modifying tables and inserting figures) and document management techniques
• Effective verbal and written communication skills including the ability to network and lead teleconferences
• Strong understanding of patient safety data, clinical database nomenclature, safety authoring conventions, and drug development
• Proven strong presentation skills, report writing skills, and customer focus skills
• Ability to deliver on multiple projects and manage competing priorities
• Ability to conduct/lead a CRM and successfully lead a project team to consensus
• Ability to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by others
• Develop professional relationships with clients as a way to further the business relationship and maintain current industry knowledge
• Ability to identify and institutionalize work practices that are most effective in order to ensure consistency

Percentage of Travel Required: 0%

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.