Katalyst CRO
Project Coordinator
North Chicago, IL – hybrid or remote, salary range $106,500.00-$202,500.00.
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.
Requirements
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.
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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.
Requirements
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.
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