Safety Project Manager

Reference #: 2017
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 departments 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.

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 departments 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

Education, Experience, Training, and Knowledge:
Bachelors 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
Skills & Abilities:
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 th business relationship and maintain current industry knowledge
Ability to identify and institutionalize work practices that are most effective in order to ensure consistency
OTHER INFORMATION:
Number of Employees Supervised: none
Percentage of Travel Required: 0%

EEO
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.

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.