Bristol-Myers Squibb Company

Global Communication Quality and Compliance Specialist

Location
Princeton, NJ, US
Posted
Nov 30, 2018
Ref
R1511822
Required Education
Bachelors Degree
Position Type
Full time
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

The Global Communication Quality and Compliance Specialist provides support for the implementation of monitoring programs to evaluate our publication development process and its compliance with company policies, procedures, and good publication practices.

The Medical Capabilities organization is a trusted, agile partner who provides medical communications to enable the Healthcare community to advance the science, accelerate access, shape medical practice, and drive appropriate adoption of BMS medicines.

The Medical Effectiveness (ME) organization within Medical Capabilities provides support to enable Field Medical readiness and effective and compliant development of publications and scientific content. ME does this through translation of the Medical Plan to develop strategy, synthesis of insights into meaningful information, and by developing and implementing technical / business solutions, standards, metrics, training and monitoring for compliance with regulations and business practices. In addition, ME is responsible for training on publication best practices; driving process improvements; and fostering alignment with good publication practices across therapeutic areas and between Global, Regional and Local medical publication groups.

The Global Communication Quality and Compliance Specialist reports to the Global Publication Practices Monitor, and provides support for the implementation of monitoring programs to evaluate our publication development process and its compliance with company policies, procedures, and good publication practices.

The Global Communication Q&C Specialist:
  • Develops plan to monitor compliance with BMS Publication related SOPs and Standards in collaboration with GPP Monitor
  • Executes monitoring activities according to the monitoring plan including but not limited to publication records in Datavision, debarment checks, Datavision access, retention schedule, financial/clinical trial transparency, and training records
  • Prepares for audits and inspections under the direction of the GPP monitor and supports GPP monitor during audits and inspections
  • Collaborates with GPP monitor and other stakeholders in the development, execution and/or tracking of corrective and preventive action plans
  • Plays a key role in developing and leading training and support related to compliance and audit/monitoring findings
  • Identifies need for process improvement related to monitoring/audit findings and collaborates with stakeholders and GPP monitor to deliver them
  • Leads development and implementation of a plan to communicate monitoring strategy, findings and recommendations to stakeholders
  • Collaborates with stakeholders and GPP Monitor to develop compliance related metrics such as agency compliance metrics, metrics before and after intervention, commitment to publish metrics and metrics related to financial transparency
  • In collaboration with the GPP monitor, partners and collaborates with key stakeholders within and outside of Medical Capabilities to bridge gaps in procedural documents, process, or documentation to minimize risk and ensure alignment with Good Publication Practices
  • Partners with and advises Datavision Publication Advisor for implementation of assessment related changes in Datavision
  • Leads reporting of publication-related transfers of value (e.g. Sunshine Act) to BMS Transparency teams to ensure accurate and timely transparency reporting
  • Ensures agency partners are assigned to training on BMS policy and procedures and removes Datavision access for agency partners who do not complete training on a timely manner
  • Serves as liaison between the clinical trial transparency and publication teams including but not limited to data sharing requests, CSR synopses reviews and commitment to publish metrics
  • Serves as a credible and influential subject matter expert on monitoring publication related compliance and transparency both within and outside of BMS
  • Provides oversight to promote adherence to Sharepoint best practices


Qualifications

• BA or BS with a minimum of 5 years-experience in the pharmaceutical or related industry

• Demonstrated competence in monitoring/auditing is preferred

• Track record of success implementing complex projects - independently and as part of a team

• Experience in good publication practices, compliance and/or financial reporting (e.g. Sunshine Act) preferred

• Datavision or similar publication management tool experience including experience using the publication data to perform complex analysis is preferred

• Experience in writing procedural documents, job aids or process instructions preferred

• Experience with working with internal and external stakeholders and demonstrated success in working in a cross functional matrix team

• Excellent organizational, written & oral communication, facilitation, interpersonal and leadership skills

• Proven experience to effectively manage timelines

• Experience working with third party vendors and influencing without authority