Reporting Support Lead - Clinical and Safety
Location
India | India
Job description
About The Role
The Reporting Support Lead- Clinical & Safety, leads a team that works to document business requirements needed to design and implement reports and metrics for the Safety and Clinical Development organizations in R&D. The role requires engagement with relevant cross-functional working groups and management of key stakeholders.
The Reporting Support Lead is responsible to act as a conduit between clinical and safety systems users and Tech colleagues to enable development of solutions that support reporting and metrics capabilities. Key activities include project management, data access enablement, metrics, reporting and analysis, dashboard and interface design, process and training support.
Key Responsibilities - The Reporting Support Lead will be accountable for:
- the design, maintenance, and support of clinical and safety reporting requirements and capabilities
- providing complex query and reporting support for business users
- developing and maintaining the requirements for a clinical and safety data mart and reporting environment
- development and management of System Access Plans and user account oversight activities
- contribution to Business Continuity planning and execution of BCP activities
- support of end users that require functionality/capability assistance and/or training
- Working in close collaboration with business owners and stakeholders to provide reporting solutions that support business processes and fulfil regulatory requirements.
- Ensuring GxP requirements and inspection readiness are maintained and current. Supporting Audit/Assessment/Inspection readiness and leading or participating in internal audits and/or external inspections as needed.
- Create the climate for continuous improvement way of working and optimize processes with the most appropriate solution considering quality, cost and business needs.
- Work across boundaries to ensure and optimize interface business partners.
- Managing the preparation, maintenance and execution of user acceptance test scripts as required. Identify opportunities for testing efficiencies and confirm that acceptance criteria have been met from the business perspective.
- Provide input for the development, enhancement, implementation and maintenance of all impacted written standards and training content.
- Oversight of applicable vendor/contract staff for relevant projects and implementations.
- Plans, monitors and manages reporting projects from initiation through completion. Leads or coordinates project planning, resourcing, reporting and troubleshooting to ensure reporting deliverables meet requirements and timelines.
Qualifications And Skills - Minimum 4 years of experience in the pharmaceutical or consumer healthcare industry in Clinical Development, Safety, Call Centre or Information Management.
- Experience in change management within global and local / market activities to drive forward new initiatives.
- Knowledge of medical and drug terminology.
- Experience / familiarity with Veeva, Power BI and/or other reporting tools.
- Experience with validated document management systems.
- Proven understanding of the GxP environment, requirements and audits and inspections.
- Business Partnership - demonstrates collaboration and partnership, ability to communicate complex issues, prioritize and align on path forward.
- Bachelor's Degree or equivalent experience.
- Demonstrated project leadership and management skills.
Preferred - Ability to work with tight deadlines.
- Ability to work cross-functionally.
- Experience with continuous improvement and agile methodologies.
- Capacity to adapt priorities, organization and promote change management.
- Excellent communication skills.
- Understands customers' needs and works with them to help solve their problems. Acts quickly to respond to customers' needs. Exhibits ability to manage and engage key stakeholders.
Care to join us. Find out what life at Haleon is really like
At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
As you apply, we will ask you to share some personal information, which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon's compliance to all federal and state US Transparency requirements.
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