• Senior Scientist, Clinical Testing Technical Writer

    The Estee Lauder Companies Melville, NY 11747

    Job #2245599571

  • Senior Scientist, Clinical Testing Technical Writer

    Brand: Estée Lauder Companies

    Description

    This role will be reporting to the ED of Claims Data Management and will be responsible for:

    • Creation, review and maintenance of policies, procedures and practices to build and ensure compliance with our enterprise goals

    • management of training curricula and training records for the Global Clinical and Consumer Science (GCCS) department

    • management of the Clinical Claims Assessment Form (CCAF) process

    • management of the vendor onboarding tracking

    Manage Controlled Documents for GCCS

    • Work with subject matter experts to create, revise, and review SOP and Work Instructions for clinical processes to ensure compliance with applicable guidelines and regulations

    • Manage uploading, review and approval of controlled documents in ELC document management system

    • Ensure appropriate

    • Provide education and training to personnel on compliance, cGCP and data integrity

    Manage departmental training program

    • Create training curricula into ELC Learning management system and upload associated quizzes

    • Assign curricula to appropriate personnel

    • Monitor the completion status of mandatory training for the department

    Manage CCAF data entry and study close out

    • Support CCAF analyst by consulting on claims terminology and results presentation

    • Meet with scientists to ensure CCAF setup and close out processes are optimized

    • Meet with stakeholders to understand needs to change the system for enhanced functionality and manage the enhancements with the IT team

    Manage the vendor onboarding process

    • Work with brand liaisons and clinical personnel to ensure the required items to onboard a new vendor are completed and acceptable

    • Maintain the vendor tracker, entering the dates of activity completion, audit requests and CAPAs and qualification status of vendors

    • Work with legal as necessary to maintain up to date master service agreements

    Qualifications

    BS in Life Sciences or related field

    5 Years Experience in a Clinical Testing environment

    5% Travel

    • Knowledge of ICH guidelines, FDA regulations and guidelines on as they pertain to clinical studies, claim substantiation, safety, data integrity and quality systems.

    • Strong background in SOP preparation and quality system implementation/maintenance.

    • Excellent written and verbal communication skills

    • Strong proficiency in MS Office suite

    Strong collaborative skills

    Job: Research & Development

    Primary Location: Americas-US-NY-Melville

    Job Type: Standard

    Schedule: Full-time

    Shift: 1st (Day) Shift

    Travel: Yes, 5 % of the Time

    Job Number: 227289

    We are an equal opportunity employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply. It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact ~~~