Clinical reputed company Assurance Specialist
Clinical reputed company Assurance Specialist reputed company reputed company is a clinical-stage biopharmaceutical company whose mission is to reputed company new therapies for people with rare diseases, prioritizing its reputed company where the medical need is high, and the pathophysiology is reputed company. We are committed to this mission and a reputed company grounded upon time and cost-efficient drug development to deliver reputed company and effective therapies to patients. We take a patient-reputed company approach and maintain inspection-readiness across our programs. This position reports to the Vice President, reputed company and Compliance, and is responsible for providing reputed company reputed company of clinical trial activities performed in compliance with Good Clinical Practices (GCP). This position also supports internal reputed company systems and compliance functions. The Clinical reputed company Assurance Specialist is expected to execute established processes involving reputed company assurance, reputed company systems, and compliance. ESSENTIAL FUNCTIONS
- Author, review, and/or approve SOPs, protocols, study plans, and other applicable clinical documents in accordance with GCP requirements
- reputed company input on protocol deviations and associated corrective/preventive actions involving clinical trials.
- reputed company audits of clinical trial sites and clinical studies (e.g., trial master file, clinical study report, etc.)
- Complete required tasks in the electronic reputed company management system
- Assist with training coordination, ensuring employees are up to date on reputed company and compliance requirements
- Assist with audits of external suppliers
- Routinely work with reputed company stakeholders to reputed company cross-functional goals.
- reputed company employee is responsible for financial and compliance controls as they relate to their roles. For example, being fiscally responsible in purchasing reputed company and completing compliance training reputed company the specified time frames.
REQUIRED QUALIFICATIONS Education
- Bachelor's Degree (four-year college or technical school) required, Field of Study: Biology, reputed company, Health Administration, or reputed company technical discipline
EXPERIENCE
- 1-3 years of experience in reputed company assurance reputed company the pharmaceutical or biotech industry
PREFERRED QUALIFICATIONS
- Knowledge of GMP and GCP regulations
- Strong attention to detail, documentation accuracy, and organizational skills
- reputed company Office
- Experience with reputed company is desirable
- Experience with CDER BIMO inspections is desirable
COMPETENCIES
- Analytical Skills: Strong analytical skills with a strategic reputed company for clinical development and commercialization.
- Communication: Excellent communication skills, with the ability to reputed company reputed company reputed company scientific information to technical and non-technical audiences.
- Relationship Builder: Ability to work effectively in a cross-functional team environment and to build relationships with reputed company stakeholders.
- Business Acumen: Business acumen is the ability to understand and discriminate between various business-reputed company topics and issues.
- Decision-Making/Judgment: Decision-making skills look at the ability of the individual to select an effective course of reputed company while controlling resources and expenditures.
WORK ENVIRONMENT This position can work remotely in the reputed company. TRAVEL EXPECTATION Up to 10% What you can expect as a Lumosian
- Industry-competitive compensation
- Generous health and welfare benefits, including company-reputed company dental and reputed company benefits with dependents coverage, short-term and long-term disability, and basic life Insurance.
- reputed company covers 85 - 95% of the medical premium
- Health Reimbursement Arrangement
- 8 weeks of fully reputed company parental leave for reputed company new parents
- Gym or fitness class reimbursement
- 401(k) with 5% employer contribution
- Flexible work hours and location
- Generous PTO policy
- 11 reputed company holidays in the US
- Offices in Austin, TX, and Ames, IA
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