Regulatory Safety Project Manager
Regulatory Safety Project ManagerJob LocationsUS-Remote CA-RemoteID2023-1641CategoryWritingPosition TypeFull-TimeOverviewThe 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.
ResponsibilitiesConduct Project Management activities to deliver quality, efficiency, and timely solutions to clientsPlan, develop, monitor, and track project schedules through an integrated project management system across clients and concurrent projectsManage budget and deliverables timelines throughout the project lifecycleManage the departmental project portfolio to meet evolving deadlines by balancing and optimizing resourcesImplement a scope change and communication process to inform all stakeholders of the related impact on time and budgetSupport 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 interactionsMay support data transfer, meeting planning, and meeting managementPerform 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 prioritiesDevelop and distribute daily, weekly, and/or monthly reporting metrics, as neededAct as a client advisor, working with all parties to lead the development of strategies for organizing and preparing narratives and safety deliverablesPractice creative and blameless problem solving, taking the department's goals and a broad perspective to resolve issues to prevent negative impact to workUsher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus on behalf of project leads, as neededMaintain collaborative, proactive, and effective communication with both client and internal teamsLead or participate in project-related meetings and teleconferences, as neededQualificationsEducation, Experience, Training, and Knowledge:
Bachelor's degree in health sciences or other directly related fieldMinimum of 5 years of experience in a project management role in either pharmaceutical, biotech, or contract research organization(s) in positions of increasing responsibilityPatient narrative writing experience required to allow anticipation of the effects that writing practice conventions may when seeking health authority approval/acceptanceKnowledge of project tracking and accounting software, Mavenlink and SmartSheet is preferred but not essentialHands-on experience in scoping and executing complex projectsPossesses a working knowledge of major regulatory authority guidelines and requirements (US, EU, and Canada preferred) enabling proactive identification and mitigation of hurdles and compliance issuesSkills & Abilities:
Intermediate proficiency with Microsoft Word (editing tools, creating and modifying tables and inserting figures) and document management techniquesEffective verbal and written communication skills including the ability to network and lead teleconferencesStrong understanding of patient safety data, clinical database nomenclature, safety authoring conventions, and drug developmentProven strong presentation skills, report writing skills, and customer focus skillsAbility to deliver on multiple projects and manage competing prioritiesAbility to conduct/lead a CRM and successfully lead a project team to consensusAbility to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by othersDevelop professional relationships with clients as a way to further the business relationship and maintain current industry knowledgeAbility to identify and institutionalize work practices that are most effective in order to ensure consistency in performance Recommended Skills Biotechnology Business Development Clinical Works Communication Data Transmissions Databases Estimated Salary: $20 to $28 per hour based on qualifications.
The SPM liaises with the internal resourcing team to ensure the appropriate assignment of authors, editors, and subject matter experts per project and client.
ResponsibilitiesConduct Project Management activities to deliver quality, efficiency, and timely solutions to clientsPlan, develop, monitor, and track project schedules through an integrated project management system across clients and concurrent projectsManage budget and deliverables timelines throughout the project lifecycleManage the departmental project portfolio to meet evolving deadlines by balancing and optimizing resourcesImplement a scope change and communication process to inform all stakeholders of the related impact on time and budgetSupport 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 interactionsMay support data transfer, meeting planning, and meeting managementPerform 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 prioritiesDevelop and distribute daily, weekly, and/or monthly reporting metrics, as neededAct as a client advisor, working with all parties to lead the development of strategies for organizing and preparing narratives and safety deliverablesPractice creative and blameless problem solving, taking the department's goals and a broad perspective to resolve issues to prevent negative impact to workUsher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus on behalf of project leads, as neededMaintain collaborative, proactive, and effective communication with both client and internal teamsLead or participate in project-related meetings and teleconferences, as neededQualificationsEducation, Experience, Training, and Knowledge:
Bachelor's degree in health sciences or other directly related fieldMinimum of 5 years of experience in a project management role in either pharmaceutical, biotech, or contract research organization(s) in positions of increasing responsibilityPatient narrative writing experience required to allow anticipation of the effects that writing practice conventions may when seeking health authority approval/acceptanceKnowledge of project tracking and accounting software, Mavenlink and SmartSheet is preferred but not essentialHands-on experience in scoping and executing complex projectsPossesses a working knowledge of major regulatory authority guidelines and requirements (US, EU, and Canada preferred) enabling proactive identification and mitigation of hurdles and compliance issuesSkills & Abilities:
Intermediate proficiency with Microsoft Word (editing tools, creating and modifying tables and inserting figures) and document management techniquesEffective verbal and written communication skills including the ability to network and lead teleconferencesStrong understanding of patient safety data, clinical database nomenclature, safety authoring conventions, and drug developmentProven strong presentation skills, report writing skills, and customer focus skillsAbility to deliver on multiple projects and manage competing prioritiesAbility to conduct/lead a CRM and successfully lead a project team to consensusAbility to use logical arguments to persuade others when presenting ideas and suggestions, but also respond positively to opposing views voiced by othersDevelop professional relationships with clients as a way to further the business relationship and maintain current industry knowledgeAbility to identify and institutionalize work practices that are most effective in order to ensure consistency in performance Recommended Skills Biotechnology Business Development Clinical Works Communication Data Transmissions Databases Estimated Salary: $20 to $28 per hour based on qualifications.
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