McKesson Sr Regulatory Specialist in The Woodlands, Texas
McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Specialty Health, our products and services span the full continuum of specialty patient care. From the initial phases of a product life cycle and the distribution of specialty drugs, to fully integrated healthcare technology systems, practice management support, and ultimately to patient care in the communities where they live, we empower the community patient care delivery system by helping community practices advance the science, technology and quality of care.
We have a vision —that the long-term vibrancy of community care will be achieved through the leadership of physicians committed to clinical excellence and innovation, enabled by close collaboration with our organization and our deep clinical, operational and technological expertise.Every single McKesson employee contributes to our mission—by joining McKesson Specialty Health you act as a catalyst in a chain of events that helps millions of people all over the globe. You’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
Join our team of leaders to begin a rewarding career.
Under minimal supervision, coordinates the regulatory and IRB activates of clinical research being conducted within the US Oncology Research network. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards. Collaborates with business units in developing compliance and business strategies. Supports design and execution of regulatory business processes.
Maintains current knowledge of FDA regulation,guidance and standards. Leads regulatory team in ensuring processes compliancewith SOP, GCP and FDA requirements.Develops metrics and reports KPI on weekly and monthly basis todepartment managers to ensure targets initiatives are being met. Investigatescomplex and unusual customer requests and complaints, develops remediation planand leads implementation. Comprehensive understanding of US Oncology Researchprocesses and operational goals.
Reviews study procedures to determine whethersupporting documents (i.e. patient diaries and surveys) are required. Compiles and submits protocol, patientinformed consent document, investigator drug brochure and all otherstudy-specific documents required for IRB approval. Makes decision that IRBsubmission package meets all criteria for review, approves or rejects
Project manages collection of requireddocumentation from research sites in accordance with FDA and trial sponsorspecifications and tracks collection progress through CTMS. Evaluates accuracyand GCP compliance of received documentation, accepts or rejects the documents.Maintains study trial master file in paper/electronic formats. Ensures file is continuously updated andprepared for audits.
Provides guidance and instruction to researchsite personnel and research central operations on regulatory affairsrequirements and procedures.
Participates in investigating regulatory issuesand disseminating regulatory findings and process changes to internal teams forimplementation.
Revising and developing new SOPs and ensuresalignment of processes with cross functional teams.
Works with research departments and trialsponsor to establish process and timelines for clinical trial activation.
Represents department in all sponsor audits,educating monitors and sponsors on SMO processes and procedures, evaluatesmonitoring visit response letters and facilitates timely responses to allaudits.
Participates in interview process to select newteam members. Trains new staff on department processes, updates and newprocedures. Updates department training manual.
Other duties as assigned
3 years in Clinical Research experience required, 2 years regulatory affairs required, project management experience is preferred
Handles day to day work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; shows resilience in the face of constraints, frustrations, or adversity; demonstrates flexibility.
Proficiency with computer systems and MicrosoftOffice (Outlook, Word, Power Point, and Excel) required.
Shows Work Commitment: Sets high standards of performance; pursuesaggressive goals and works efficiently to achieve them
4-year degree in a related field.
Possesses up to date knowledge of the professionand industry; is regarded as an expert in the technical/functional area;accesses and uses other expert resources when appropriate
Environment (Office, warehouse, etc.) – The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office environment. Requires significant interaction with clinical and corporate staff.
Physical Requirements (Lifting, standing, etc.) – The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle or feel. The employee is occasionally required to stand, walk and reach with hands and arms. The employee must occasionally lift and/or move up to 40 pounds. Requires vision and hearing corrected to normal ranges.
Benefits & Company Statement
McKesson believes superior performance – individual and team – that helps us drive innovations and solutions to promote better health should be recognized and rewarded. We provide a competitive compensation program to attract, retain and motivate a high-performance workforce, and it’s flexible enough to meet the different needs of our diverse employee population.
We are in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. We partner with payers, hospitals, physician offices, pharmacies, pharmaceutical companies and others across the spectrum of care to build healthier organizations that deliver better care to patients in every setting.
But we can’t do it without you. Every single McKesson employee contributes to our mission—whatever your title, whatever your role, you act as a catalyst in a chain of events that helps millions of people all over the globe. Talented, compassionate people are the future of our company—and of healthcare. At McKesson, you’ll collaborate on the products and solutions that help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.
McKesson is an equal opportunity and affirmative action employer – minorities/females/veterans/persons with disabilities.
Qualified applicants will not be disqualified from consideration for employment based upon criminal history.
No agencies please.
Job: Project Management
Organization: McKesson Specialty Health
Title: Sr Regulatory Specialist
Location: Texas-The Woodlands
Requisition ID: 18001809