McInnis Inc.
Overview
The Medical Publications (Med Pubs) Manager/Compliance Monitor will work closely with the Med Pubs Senior Associate Directors (SAD), Scientific Communications Director, and the Compliance/Legal Business Partners to monitor documentation contained within the electronic publications database (EPD, i.e., Datavision) to ensure that the Medical Publications Group is compliant with all external and internal processes, guidelines, regulations, and requisites. The primary role is the maintenance, interrogation, and analysis of the electronic publication databases to ensure 100% compliance based on identified audit parameters. The Manager will serve as a liaison between personnel and external agencies to ensure adherence to compliance requirements and will assist the Med Pubs SADs in managing the execution of their scientific publication plans in support of the strategic business direction of Client-supported products. Remote Position Job Type:
Full-Time Salary:
$47,000 - $51,000 per year Benefits:
Medical, Vision, Dental Responsibilities and Duties
Creation and management of Medical Publications databases within multiple therapeutic areas, including tactical management of the Datavision compliance work stream and document integration. Assist in the maintenance of the EPD to ensure compliance with Client Publications Policies. Serve as a primary liaison between Medical Publications and the Ethics and Compliance Monitor to ensure seamless compliance reporting. Collaborate with the Med Pubs SADs on all aspects of publication planning, development, and execution of Client-sponsored publication plans. Manage the Client review of publications emanating from Investigator-Initiated Studies (IISs), Scientific Advancement Grants (SAGs), Quality Improvement Education (QIEs), and External Collaborative Research (ECRs). Manage publications agencies through effective project management to ensure timely and quality delivery of documents. Medical Publication Manager I
Preferred Experience: Previous work with a Medical Communications agency Experience in managing publication plans Project management skills; excellent written and verbal communication skills Knowledge of external publication guidelines (e.g., ICMJE, GPP) Knowledge of Datavision software Vendor management experience Role and Responsibilities: Responsible for the management of tactical operations of publications (with oversight from the Med Pubs SADs), including management of publication projects, tactical planning with agencies, tracking timelines and progress, following up with authors/agencies, and budget monitoring. Supports special publications projects across multiple therapeutic areas Logistics support for projects and special working groups as needed Supports full compliance with all aspects of relevant Medical Publications policies, EPD system (Datavision) and SOPs Attendance and contribution to Publication Team meetings Creates executive summaries of high-level meetings Medical Publication Manager II
Preferred Experience: Previous work with a Medical Communications agency Experience in managing publication plans Project management skills; excellent written and verbal communication skills Knowledge of external publication guidelines (e.g., ICMJE, GPP) Expert user of Datavision software Vendor management experience Advanced scientific degree preferred Role and Responsibilities: Responsible for the management of tactical operations of publications (with oversight from the Med Pubs SADs), including management of publication projects, tactical planning with agencies, tracking timelines and progress, following up with authors/agencies, and budget monitoring. Supports special publications projects across multiple therapeutic areas Logistics support for projects and special working groups as needed Supports full compliance with all aspects of Medical Publications policies, EPD system (Datavision) and SOPs Communicates publication plans to cross-functional stakeholders as necessary Creates and leads training of internal and external stakeholders on publication processes Serves as operational publications lead across therapeutic areas Ability to understand and implement scientific and business strategy Ability to critically evaluate and recommend solutions to improve processes and workflows General Responsibilities
The Medical Publications (Med Pubs) Manager/Compliance Monitor will work closely with, and report to, Med Pubs SADs, the Scientific Communications Director, and the Compliance/Legal Business Partners to monitor documentation contained within the electronic publications database (EPD, i.e., Datavision) to ensure that the Medical Publications Group is compliant with all external and internal processes, guidelines, regulations, and requisites. The primary role is the maintenance, interrogation, and analysis of the electronic publication databases to ensure that these databases reach 100% compliance based on identified audit parameters. The Manager will serve as a liaison between personnel and external agencies to ensure adherence to compliance requirements and will assist the Med Pubs SADs in the management of the execution of their respective scientific publication plans in support of the strategic business direction of Client-supported products. Knowledge and Qualifications: Knowledge of Medical Publications Best Practices (ICMJE, GPP) preferred. Ability to work in cross-functional teams to develop and manage innovative publications strategies and plans. Experience working with senior colleagues and external investigators and authors to deliver timely and quality publications. Ensure compliance with the company Publications Policy and efficiently manage external agencies and suppliers. Creation and management of Medical Publications databases within multiple therapeutic areas (Datavision); document integration. Notes: EEO statements and other required notices may be included as applicable; this description preserves the original content while ensuring accessibility and compliance with formatting guidelines.
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The Medical Publications (Med Pubs) Manager/Compliance Monitor will work closely with the Med Pubs Senior Associate Directors (SAD), Scientific Communications Director, and the Compliance/Legal Business Partners to monitor documentation contained within the electronic publications database (EPD, i.e., Datavision) to ensure that the Medical Publications Group is compliant with all external and internal processes, guidelines, regulations, and requisites. The primary role is the maintenance, interrogation, and analysis of the electronic publication databases to ensure 100% compliance based on identified audit parameters. The Manager will serve as a liaison between personnel and external agencies to ensure adherence to compliance requirements and will assist the Med Pubs SADs in managing the execution of their scientific publication plans in support of the strategic business direction of Client-supported products. Remote Position Job Type:
Full-Time Salary:
$47,000 - $51,000 per year Benefits:
Medical, Vision, Dental Responsibilities and Duties
Creation and management of Medical Publications databases within multiple therapeutic areas, including tactical management of the Datavision compliance work stream and document integration. Assist in the maintenance of the EPD to ensure compliance with Client Publications Policies. Serve as a primary liaison between Medical Publications and the Ethics and Compliance Monitor to ensure seamless compliance reporting. Collaborate with the Med Pubs SADs on all aspects of publication planning, development, and execution of Client-sponsored publication plans. Manage the Client review of publications emanating from Investigator-Initiated Studies (IISs), Scientific Advancement Grants (SAGs), Quality Improvement Education (QIEs), and External Collaborative Research (ECRs). Manage publications agencies through effective project management to ensure timely and quality delivery of documents. Medical Publication Manager I
Preferred Experience: Previous work with a Medical Communications agency Experience in managing publication plans Project management skills; excellent written and verbal communication skills Knowledge of external publication guidelines (e.g., ICMJE, GPP) Knowledge of Datavision software Vendor management experience Role and Responsibilities: Responsible for the management of tactical operations of publications (with oversight from the Med Pubs SADs), including management of publication projects, tactical planning with agencies, tracking timelines and progress, following up with authors/agencies, and budget monitoring. Supports special publications projects across multiple therapeutic areas Logistics support for projects and special working groups as needed Supports full compliance with all aspects of relevant Medical Publications policies, EPD system (Datavision) and SOPs Attendance and contribution to Publication Team meetings Creates executive summaries of high-level meetings Medical Publication Manager II
Preferred Experience: Previous work with a Medical Communications agency Experience in managing publication plans Project management skills; excellent written and verbal communication skills Knowledge of external publication guidelines (e.g., ICMJE, GPP) Expert user of Datavision software Vendor management experience Advanced scientific degree preferred Role and Responsibilities: Responsible for the management of tactical operations of publications (with oversight from the Med Pubs SADs), including management of publication projects, tactical planning with agencies, tracking timelines and progress, following up with authors/agencies, and budget monitoring. Supports special publications projects across multiple therapeutic areas Logistics support for projects and special working groups as needed Supports full compliance with all aspects of Medical Publications policies, EPD system (Datavision) and SOPs Communicates publication plans to cross-functional stakeholders as necessary Creates and leads training of internal and external stakeholders on publication processes Serves as operational publications lead across therapeutic areas Ability to understand and implement scientific and business strategy Ability to critically evaluate and recommend solutions to improve processes and workflows General Responsibilities
The Medical Publications (Med Pubs) Manager/Compliance Monitor will work closely with, and report to, Med Pubs SADs, the Scientific Communications Director, and the Compliance/Legal Business Partners to monitor documentation contained within the electronic publications database (EPD, i.e., Datavision) to ensure that the Medical Publications Group is compliant with all external and internal processes, guidelines, regulations, and requisites. The primary role is the maintenance, interrogation, and analysis of the electronic publication databases to ensure that these databases reach 100% compliance based on identified audit parameters. The Manager will serve as a liaison between personnel and external agencies to ensure adherence to compliance requirements and will assist the Med Pubs SADs in the management of the execution of their respective scientific publication plans in support of the strategic business direction of Client-supported products. Knowledge and Qualifications: Knowledge of Medical Publications Best Practices (ICMJE, GPP) preferred. Ability to work in cross-functional teams to develop and manage innovative publications strategies and plans. Experience working with senior colleagues and external investigators and authors to deliver timely and quality publications. Ensure compliance with the company Publications Policy and efficiently manage external agencies and suppliers. Creation and management of Medical Publications databases within multiple therapeutic areas (Datavision); document integration. Notes: EEO statements and other required notices may be included as applicable; this description preserves the original content while ensuring accessibility and compliance with formatting guidelines.
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