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Director, Publications Planning

Job Description

POSITION SUMMARY:

As Intercept continues to build its position as the leader in progressive non-viral liver disease, we are seeking a Director, Publications Planning. This position is responsible for the development and execution of scientific and communication initiatives, and works closely with key internal and external stakeholders to optimize the publication projects including but not limited to abstracts, congress presentations, and manuscripts.

The Director, Publications Planning will report to and partner with the Vice President of Medical Writing to create and further develop strategic and tactical lifecycle management plans. This position may oversee team members responsible for publication projects in alignment with company medical strategies.Publications Planning creates and updates Global Publication Plans and related tactics (e.g. abstracts, congress presentations, manuscripts) and supports cross-functional teams involved in publication activities.

This position provides appropriate direction to external agencies/consultants to support various timely projects, in a cost-effective manner. This position communicates regular status updates to internal stakeholders and applies disease-area and product expertise to a wide variety of cross-functional projects, including the adoption of publication-related best practices, management systems and processes across the entire organization. This position partners with Compliance/Legal to design, conduct internal quality inspections, monitor, develop and update audit-readiness guidance documents.

CORE ACCOUNTABILITIES:

The successful candidate must be able to perform each of the following satisfactorily:

  • Mentor, motivate, empower, and act as a role model to medical writing team members.
  • Demonstrate strong stakeholder centricity, ability to influence with or without authority, and execute change management, translating high-level business needs and objectives into actionable plans.
  • Interpret and synthesize complex clinical/scientific findings, statistical reports. Translate findings and adapt messages for diverse audiences. Responsible for the execution of the medical strategies and objectives into an actionable Global Publication Plan (GPP) for Ocaliva┬« across liver diseases.
  • Optimize partnerships to ensure all congress planning activities reflect medical strategies. Ensure broad cross-functional alignment, execute an all-inclusive annual publication planning meeting to address and revisit unmet needs, gaps, SWOT, assessment of the scientific/competitive landscape.
  • Ensure the overall oversight, update and execution of the strategic and tactical GPP in alignment with the approved medical strategies, data availability, changes in the regulatory and access landscapes globally and in markets of interest. Gain endorsement of the GPP by governance bodies per company process prior to plan execution.
  • Establish efficient and user-friendly processes to remove unnecessary silos and bottle necks.
  • Develop publication key performance indicators (KPIs), generate analytic reports related to publication projects.
  • Serve as subject matter expert and demonstrate deep understanding of various disease areas, medical strategies and objectives required to provide input and guidance on matters related to publication planning and data disclosure.
  • Demonstrate disease state expertise and knowledge of current medical and/or regulatory issues related to company products, provide scientific/clinical direction.
  • Foster collaborative relationships with academic and clinical experts, publishers, medical associations and other relevant external and internal stakeholders.
  • Oversee the overall publication budget and resource utilization, monthly reporting, forecasts and budget plans. Collaborate with Procurement for periodical vendor business reviews and RFP assessments.
  • Responsible for the development, maintenance, rollout and adherence to corporate policies, SOPs, WPs describing Intercept's publication practices. Proactively provide expertise and train stakeholders on publication-related best practices and industry trends to optimize adoption.
  • Support publication standardization to ensure consistent and compliant practices across cross-functional teams involved in publication activities (e.g. Affiliates, Market Access, etc.) and as per company process.
  • Partner with VP, Medical Writing and Compliance/Legal to design, conduct internal quality inspections, monitor, and develop audit readiness procedures.
  • Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
  • Drive the spirit of \"ONE Team\" across all functions by supporting a team approach to focus on our patients and customers as our top priorities
  • Make Intercept a truly desired place to work



Experience and Skills

QUALIFICATIONS:

  • Scientific or graduate level degree (PhD, PharmD, DO, MSc, NP, PA, etc.).
  • Minimum of 8 years of industry experience (preferably in Scientific Communications or Publication Agency).
  • Global, pre- and post-product launch experience.
  • Member of a professional society (ISMPP, TIPPA, MAPS), being CMPP certified is a plus.


REQUIRED KNOWLEDGE AND ABILITIES:

  • Ability to prioritize concurrent projects with tight deadlines and operate in a highly compliance-driven environment.
  • Expertise with relevant publication-related recommendations and guidelines (e.g. ICMJE, GPP3, HIPAA, GRDP, Sunshine Act, etc.).
  • Ability to interpret and synthesize complex clinical/scientific findings, statistical reports, translate findings and adapt messages for diverse audiences.
  • Excellent written, verbal and interpersonal skills, and the ability to communicate at all levels within the company.
  • Flexibility of approach and a positive attitude.
  • Proficiency with Microsoft Office applications and hands-on experience with various management systems (e.g. Datavision, SharePoint, Veeva, etc.).
  • A global mindset and foreign languages are considered strong assets.
  • Travel may be required to represent company at medical conferences, presentations, and other meetings.
  • Strong verbal and written communication skills
  • Learning agility and 'scalability' to take on increasing responsibility as Intercept grows
  • Consistent demonstration and embodiment of company core values: Come Together, Be Yourself, Own the Solution, Embrace the Challenge, Keep Exploring.
  • Ability to have fun and thrive in a growing, diverse, and inclusive work environment



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Director, Publications Planning

Morristown, NJ 07960
Full Time

Published on 06/17/2022

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