The Senior Publication Operation Manager assists with the execution of the global publication plan and related projects in peer reviewed journals and scientific congresses. The Scientific Communication Team is a critical group within Medical Affairs which is responsible for the development and execution of internal and external scientific communication strategy and related tactics. The SciCom Team is also accountable for working closely with key internal and external stakeholders to optimize the accuracy and quality of publication projects including but not limited to abstracts, congress presentations, and manuscripts. The Sr. PubOps Manager is responsible for supporting the Ex. Director SciCom to ensure that the department develops and delivers publication tactics efficiently and consistently, while adhering to corporate policies and regulations. The Sr. PubOps Manager is engaged in the cross-therapeutic publication team, supports submissions and tracks publication projects, and is involved in the annual publication plan (i.e. gap analysis, needs assessments, SWOT, etc.). The Sr. PubOps Manager will establish strong partnerships with the SciCom therapeutic team members and internal cross-functional stakeholders to support the implementation of best publication practices and processes. Activities related to this role also include optimal departmental efficiency, audit readiness, consistency, and appropriate resource utilization.
To perform this job successfully, an individual must be able to execute each of the following essential functions:
Serve as a subject matter expert on departmental databases, repositories, project planning, management tools, providing support to therapeutic teams to ensure consistent storage of documents and other materials.
Develop Key Performance Indicators (KPIs), generate analytic reports related to publications, congress submissions from Intercept's sponsored studies and our independent investigator research (IIR) program.
Identify potential timeline risks, issues, and deviations from plans; communicate with the SciCom team and collaborate towards finding pragmatic solutions.
Work with the Ex. Dir. SciCom and the finance department to develop and track budgets identify needs; participate in annual budget and forecasts.
Responsible for access and ongoing training across systems (e.g. Datavision, Veeva Vault, SlideBank, etc.). Identify and communicate any gaps, updates and/or enhancements needed for our various platforms.
Ensure Datavision is effectively utilized to support the review/approval process, archiving and maintenance of all Intercept publication projects.
Work collaboratively with various geographies across therapeutic areas.
Support standardization to ensure consistent, compliant and best in class publications.
Facilitate other administrative activities (e.g. poster printing & shipping, abstract and manuscript submissions, facilitate reviews with alliance partners, etc.).
Assist KOLs during the review, approval and submission of publication projects.
Support the Ex. Dir. SciCom, Compliance/Legal partners in the design and conduct of quality inspection, monitoring and audit readiness procedures.
Assist with in updating and development of Policies and standard operating procedures (SOPs) as well as work practices (WPs).
Bachelor's degree in a scientific field or other relevant field is required
Work experience in the pharmaceutical/biotech industry in project management is required as well as knowledge of the drug development process (>3 years).
Experience in publication planning (ISMPP membership, CMPP certification- >3 years)
Awareness of compliance issues and guidelines around medical education and publications practices (ICMJE, GPP3, GRDP, Sunshine Act, etc.).
Strong inter-personal skills and problem-solving capabilities.
Strong customer focus and interpersonal skills.
Flexibility, positive attitude, strong ability to multitask, and to prioritize projects effectively and communicate at all levels within the company.
Proven meeting planning and facilitation skills.
Ability to work with cross-functional teams, and to execute multiple project simultaneously, and in a timely and cost-efficient manner.
Excellent written, verbal and interpersonal communication skills.
A global mindset and foreign languages are considered strong assets.
Able to create, track and plan timelines and budgets.
Ability to manage external vendors and provide clear, concise guidance.
Proficiency with Microsoft Office applications, and experience working with document management systems (e.g. Datavision, SharePoint, Veeva Vault, etc.).
Some travel may be required to represent company at medical conferences, presentations, and other meetings.
Intercept Pharmaceuticals, Inc.