Katalyst CRO · 3 months ago
Project Coordinator II
North Chicago, IL
Contract
Onsite
Mid Level
3+ years expKatalyst CRO is a company focused on providing innovative solutions in the clinical research field. They are seeking a Project Coordinator II to oversee and coordinate activities related to Client Aesthetics reference management, ensuring timely approvals and compliance with documentation processes.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Oversee and coordinate activities related to Client Aesthetics reference management, including both Medical and Commercial Data on File (DoF) packets
Manage creation, review, and submission of DoF Intellectual Property (IP) and Non-IP packets, ensuring proper documentation and timely approvals from key stakeholders
Facilitate the uploading and processing of approved DoF packets in Veeva Vault (PromoMats), working closely with the Global Vault Library team for seamless reference integration
Establish and communicate clear timelines for reference approval, re-approval, and necessary updates, proactively resolving any issues that arise
Ensure accurate attachment of DoF IP and Non-IP references to supporting content, replacing with published articles as appropriate
Maintain and update the master reference list on SharePoint, supporting the processing of denied, migrated, and current requests
Lead efforts to identify, source, and submit public/third-party references to support non-promotional materials, ensuring compliance and completeness throughout the review process
Collaborate with cross-functional teams to evaluate and create new references or manage the rejection of requests, optimizing operational efficiency
Oversee the process to ensure non-promotional content and all associated components (images, video, sound, text, etc.) have appropriate copyright permissions for intended use
Manage the acquisition, tracking, and maintenance of copyright permissions and related documentation in an organized repository for Client Aesthetics
Monitor and maintain the budget for copyright permissions, ensuring cost efficiency and compliance with organizational guidelines
Oversee the regular updating and maintenance of procedural documentation, including quick reference guides, master reference lists, copyright repositories, compliance deviation records, and content guidance documents for Client Aesthetics
Ensure process documents related to Veeva Vault workflows and compliance are consistently accurate and standardized
Coordinate with cross-functional teams to implement best practices and address gaps in documentation, supporting operational excellence and regulatory compliance
Provide support with additional ad hoc projects related to approval of non-promotional materials, as required by the business
Effectively communicate and support multi-functional groups or project teams
Assist with newsletters, analytical reports, and field tool overviews to support business metrics and medical affairs
Qualification
Required
Bachelor's degree in life sciences, pharmacy, business, or a related field
3-5 years of experience in project management, preferably in pharmaceutical, biotech, or healthcare settings
Familiarity with Medical Affairs processes, including publications, data of file/unpublished data, and compliance
Proficiency in MS Office software (e.g., MS Outlook, PowerPoint, Excel, SharePoint, etc.)
Knowledge of Veeva Vault (PromoMats and/or MedComms) strongly recommended
Strong organizational, multitasking, and time management skills
Ability to collaborate with cross-functional teams and stakeholders
Excellent verbal and written communication abilities
Attention to detail and problem-solving skills
Willingness to learn and adapt within a dynamic, fast-paced environment, and enjoys working for a global organization of highly complex business scenarios
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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