The Medical Publications (Med Pubs) Manager/Compliance Monitor will work closely with, 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 of the Med Pubs Manager will be 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. The Manager will also 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 understanding of Medical Publications Best Practices (ICMJE, GPP) is preferred. Candidates for this position must be able to work in cross-functional teams to assist in the development and management of innovative publications strategies and plans, work 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 database(s) within multiple therapeutic areas. This will include tactical management of the Datavision compliance work stream and document integration
Assists 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.
Works closely with the Med Pubs SADs on all aspects of publication planning, development, and execution of Client-sponsored publication plans.
Manages the Client review of publications emanating from Investigator-Initiated Studies (IISs), Scientific Advancement Grants (SAGs), Quality Improvement Education (QIEs), and External Collaborative Research (ECRs)
Manages publications agencies through the effective use of project management skills to ensure timely and quality delivery of documents.
Medical Publication Manger I
Preferred Experience:
Previous work with Medical Communications agency
Experience in managing publication plans
Project management skills; excellent written and verbal communication skills
Knowledge of external publication guidance’s (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) which includes 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 all relevant Medical Publications policies, EPD system (i.e., 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 Medical Communications agency
Experience in managing publication plans
Project management skills; excellent written and verbal communication skills
Knowledge of external publication guidance’s (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) which includes 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 all relevant Medical Publications policies, EPD system (i.e., Datavision) and SOPs
Attendance and contribution to Publication Team meetings
Creates executive summaries of high-level meetings
Support the Med Pubs SADs in the tactical execution and implementation of Medical Publications activities across more than one therapeutic area or asset
Support the Med Pubs SADs in strategic planning as needed, including co-leading with oversight from the Med Pubs SADs.
Lead and provide oversight for established publication plans
Supports full compliance with all aspects of all relevant Medical Publications policies, EPD system (i.e., 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