Develop strategy and manage the Quality programs across Scientific Communications Operations to ensure process compliance, identify gaps and initiate improvements.
Provide direction to Scientific Communications organization and external vendor management on quality processes and procedures, compliance and audit readiness of Scientific Communications owned processes. This also includes providing direction or guidance to any vendors/grantees working on behalf of BIPI who might be involved in the recognition, collection and communication of medical related or other data and the outsourcing of BIPI Scientific Communications managed functions.
Partner with Clinical Development and Medical Affairs (CDMA) and BI business functions to support strategic decision making for outsourcing. Collaborate on and/or facilitate the execution of required internal and external audits in compliance with critical business processes, key regulations (e.g. Sunshine) and document management (e.g., Document retention and Hold).
Oversee the creation, management and updating of Scientific Communications Operation's and vendor collaborated SOPs and WIs to ensure alignment with system and business processes and changes, as well as contractual requirements and obligations. Partner with Global Process Owners (GPO) to ensure local processes are aligned with global procedures and local regulations.
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities\:
- Strategic Planning
- Develop strategy and manage the Quality programs across Scientific Communications Operations to ensure process compliance, identify gaps and initiate improvements.
- Develop and execute detailed audit readiness methodology, policy and guidance.
- Partner with cross-functional management within Medicine, Strategic Sourcing, during vendor identification and procurement to ensure thoughtful consideration of quality measures and applicant performance. Manages the above in-line with the Global Supplier Management SOP.
- Partners with the CDMA Scientific Communications leadership to develop a vendor oversight strategy. Collaborates with Ethics and Compliance and Quality Medicine in determining required audits of internal business process and with Scientific Communications leadership to align on measures for performance.
- Execution Vendor Monitoring
- Develops and operates a quality monitoring program that utilizes all methods for quality monitoring to ensure vendors are aligned with BIPI processes, policies and expectations and mitigate risks and non-compliances.
- Creates and maintains a quality program to periodically audit contact center vendor partners for adherence to contract, regulation, service agreements and BI policies. Assures that all aspects of the relationship (technical, operational, legal and financial) are defined and adhered to.
- Continuously evaluates, communicates impact of programs to company as well as records the outsourcing and outside vendor needs of contact centers at BIPI.
- Works collaboratively with Contact Center Lead to ensure implementation of any vendor directed CAPAs.
- Ensure that all business process documents are managed in accordance with defined applicable Corporate and local SOPs, WIs, policies, guidelines and regulations. Modify and update local WI and supporting processes and templates as appropriate.
- Identify audit opportunities and conduct a due diligence investigation of issues for compliance auditing.
- Collaborate with training and operation leads to, manage and maintain master training and quality matrix. Responsible for archiving of all audit material.
- Develop Process Improvement Program.
- Partners with Ethics and Compliance interpreting findings as well as collaborate with E&C and Scientific Communications Leaders to define and implement any CAPAs.
- Proactively access quality risks in accordance with all regulations (e.g. FDA, "PhRMA Guidelines, etc.) and Company policies summarized in the relevant BIPI SOPs or Local Working Instructions. Continuously monitors and, as needed, improves processes to mitigate compliance risks.
- Demonstrates high ethical and professional standards with all customers in order to maintain BIPI's reputation within the medical and pharmaceutical community.
- Bachelor degree from an accredited institution required with a minimum of seven (7) years of experience in the pharmaceutical industry and experience working with vendors, preferably in the context of medical information or medical education.
- Five-plus (5+) years of quality management experience.
- Experience with Project Planning and management of organizational processes related to Medical Information, Medical Call Center, Medical Education, Research trials and Medical Publications, including documentation standards and compliant business practice.
- Influencing without authority.
- Ability to manage vendor interactions and work collaboratively with cross-functional stakeholder inputs.
- Familiar with all applicable regulations, guidance's, and industry standards as related to clinical research and pharmaceutical company interactions with health care providers (HCPs).
- In-depth knowledge of OIG, FDA and other relevant current government, industry, and organizational guidelines preferred.
- Prior experience working in a complex business arrangement with outside business partners.
- Possess basic knowledge regarding Scientific Communications functions (e.g., Medical information, Medical Publications, etc.), supportive vendors and their processes.
- Must be capable of independently managing multiple projects and prioritizing efforts based on business needs. Ability to manage a large volume of transactional information with accuracy and attention to detail.
- Demonstrated ability to work cross-functionally at the franchise level and at all levels across the enterprise.
- Exhibits flexibility in working collaboratively across internal and external stakeholders.
- Ability to working effectively through others.
- Possesses excellent communication, presentation and organizational skills.
- Proficiency with precision measuring tools.
- Excellent analytical and problem solving skills.
- Strong knowledge of calibration and controls to measure compliance.
Who We Are\:
- Must be legally authorized to work in the United States without restriction.
- Must be willing to take a drug test and post-offer physical (if required).
- Must be 18 years of age or older.
At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. Learning and development for all employees is key because your growth is our growth.
Want to learn more? Visit boehringer-ingelheim.com
and join us in our effort to make more health.
Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.