Summary of Responsibilities:
Follow applicable departmental Standard Operating Procedures and Work Instructions.
Complete required trainings according to required timelines.
Administer controlled documents ensuring availability to the end user.
Track and report metrics as determined by management according to required timelines.
Assist with implementation of new/revised processes and procedures.
Demonstrated ability to communicate effectively.
Perform checks to ensure quality of work completed.
Ensure timely escalation and resolution management of issues impacting controlled document release.
Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed.
All other duties as needed or assigned.
Qualifications (Minimum Required):
3 years in regulatory environment (experience in GXP roles).
Demonstrated ability to plan, prioritize, organize and communicate effectively.
Demonstrated ability to pay attention to detail.
Strong analytical skills.
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
Experience (Minimum Required):
3 years in regulatory environment (experience in GXP roles).
Strong interpersonal skills with ability to work well with others.
Ability to deliver consistent high quality of work.
Ability to use computer and departmental tools.
Physical Demands/Work Environment:
Tasks involve sitting in front of a terminal for many hours during the working day.
Should be comfortable working in 2nd shift hours (2 - 11 PM IST)
Learn more about our EEO & Accommodations request here.
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network.
Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
