Bristol-Myers Squibb

Publications Compliance Manager

Posted on: 5 Mar 2021

Princeton, NJ

Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Medical Capabilities organization at BMS 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 WW Medical Compliance & Governance organization within Medical Capabilities supports the compliant development of publications and scientific content. Our team is accountable for developing and implementing standards for development of Scientific Publications and related content, training and
monitoring, process improvements and business/technical solutions.

The Publications Compliance Manager is a matrix subject matter expert for minimizing risk related to publications. The Publications Compliance role leads the development and implementation of the monitoring plan to evaluate adherence to company policies and procedures. In addition, the Publications Compliance Manager is the business lead for the BMS publication management tool to ensure that the tool and training align to the documentation requirements in company policies and procedures. The Publications Compliance position is responsible for setting the standards for
documentation practices, BMS specifications for the documentation tool and related training for internal employees and external partners. The Publications Compliance Manager reports to the Publications Compliance Lead.

Responsibilities:
Facilitates identification and prompt escalation of compliance risks and related issues along with mitigation strategies to appropriate stakeholders and/or functional management, to expedite resolution. Proactively analyzes and drives efficient problem solving. Applies critical thinking to
manage complex issues. Effectively leads team in identification of issues, highlighting risks, developing mitigation and resolution strategies, and responding to action items.
Develops plans to monitor compliance with BMS Publication SOPs and Standards. Executes monitoring activities according to the monitoring plan including but not limited to publication records in management tool, debarment checks, financial transparency and training completion. Communicates the monitoring plans, findings and recommendations to internal stakeholders and agency partners. Collaborates with stakeholders in the development, execution and/or tracking of corrective and preventive actions(CAPAs) to address the root causes for the findings.
Prepares for audits and inspections and provides supports during and after audits and inspections as needed. Collaborates in the execution and/or tracking of audit CAPAs.
Collaborates with stakeholders in process improvement efforts impacting compliance risks, documentation and/or documentation tool.
Leads the development and delivery of training and support (including onboarding) related to compliance, audit/monitoring findings, documentation practices in publication tool as well as BMS requirements and specifications (not related to IT) for publication tool.
Develops metrics related to compliance such as agency compliance metrics, metrics before and after intervention and other metrics related to financial transparency.
Contributes to the Medical Capabilities Agency Governance by providing insights about agencies performance related to compliance and documentation.
Partners and collaborates with stakeholders to bridge gaps in procedural documents, process, Datavision and/or documentation to minimize risk and ensure alignment with Good Publication Practices.
Leads reporting of publication-related transfers of value (e.g. Sunshine Act) to BMS Transparency teams to ensure accurate and timely transparency reporting. Ensures business rules in automated reporting tool reflects current legal and voluntary external requirements (e.g. CMS, EFPIA).
Serves as a credible and influential subject matter expert on publication related compliance and documentation within and outside of BMS.

Qualifications
BA or BS with a minimum of 3 years-experience in the pharmaceutical or related industry (e.g. communications agency) preferred
Experience in good publication practices and/or publication management tool required
Certified Medical Publication Professional (CMPP) and/or ISMPP active member highly desired
Experience in financial reporting (e.g. Sunshine Act) and/or monitoring/auditing preferred
Experience using data to perform complex analyses and monitor compliance preferred
Track record of successful implementation of complex projects independently and as part of a cross functional matrix team
Excellent organizational, written & oral communication, facilitation, interpersonal and leadership skills
Experience working with third-party vendors and influencing without authority

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Bristol-Myers Squibb

New York, New York

Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. The company offers drugs in oncology, immunoscience, cardiovascular, and fibrotic diseases. The company’s products include Opdivo, a biological product for anti-cancer indications; Eliquis, an oral inhibitor targeted at stroke prevention in adult patients with non-valvular atrial fibrillation, and the prevention and treatment of venous thromboembolic disorders; and Orencia, a biological product for adult patients with moderately to severely active RA and prostate-specific antigen, as well as reducing signs and symptoms in certain pediatric patients with moderately to severely active polyarticular juvenile idiopathic arthritis.

It also provides Sprycel, a tyrosine kinase inhibitor for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia; Yervoy, a monoclonal antibody for the treatment of patients with unresectable or metastatic melanoma; Empliciti, a humanized monoclonal antibody for the treatment of multiple myeloma; and Baraclude, an oral antiviral agent for the treatment of chronic hepatitis B. In addition, the company offers Reyataz, a protease inhibitor for the treatment of human immunodeficiency virus (HIV) and Evotaz; Sustiva franchise, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV; and Daklinza NS5A replication complex inhibitor, Sunvepra NS3 protease inhibitor, and Beclabuvir NS5B inhibitor. It sells products to wholesalers, retail pharmacies, hospitals, government entities, and medical profession. It has collaboration agreements with Nektar Therapeutics; Janssen Pharmaceuticals, Inc.; Biocartis Group NV.; and FameWave Ltd.

The company was formerly known as Bristol-Myers Company and changed its name to Bristol-Myers Squibb Company in 1989. Bristol-Myers Squibb Company was founded in 1887 and is headquartered in New York, New York.

  • Industry
    Biopharmaceuticals
  • No. of Employees
    23, 300
  • Jobs Posted
    1641

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