Senior Regulatory and Start Up Specialist, Brazil

🔥 6 minutes ago

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Deliver timely, high-quality site activation readiness for assigned country/sites and mitigate risks • Prepare Clinical Trial Application forms and submission dossiers for Competent Authorities, Ethics Committees, and other local bodies • Interact with Competent Authorities and Ethics Committees and handle responses • Provide submission updates to Start Up/Regulatory Leads and project teams • Maintain project plans, trackers, regulatory intelligence tools, and regulatory leadership updates • Support study-specific start-up plans, IMP release requirements, and essential document review criteria • Partner with assigned site CRAs to align communication and secure site collaboration • Prepare, review, and manage essential documents for site activation and IMP release • Customize country/site-specific Patient Information Sheets and Informed Consent Forms • Coordinate translations of submission documents • Communicate with Feasibility, Clinical Operations, Project Management, Regulatory, and Site Contracts teams regarding status and deliverables • Act as subject matter expert for site activation critical-path data, regulatory timelines, contracts, budgets, and required reviews • Support study budget negotiations and investigator contract execution when required • Maintain knowledge of local clinical trial laws and regulations and distribute regulatory knowledge internally • Maintain audit and inspection readiness and file documents in the relevant TMF • Support Pre-Study Site Visits, site feasibility outreach, country start-up summaries, training sessions, and staff mentoring as needed • Provide clients with activation-readiness updates and support proposal activities • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree in life sciences or related field, or Registered Nurse (RN), or equivalent combination of education, training, and experience • 3.5 years or more of Regulatory or Site Start-Up specialist experience in a CRO or pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies • Professional-level English proficiency in verbal and written communication • Fluency in English and the local language for the country where the position is based • Experience using computerized information systems, electronic spreadsheets, word processing, and electronic mail • Excellent communication and organizational skills • Ability to prioritize workload and meet deadlines • Knowledge of Good Clinical Practice, ICH Guidelines, and applicable regulatory requirements • Ability to interact effectively with project teams and communicate in English and the local language • Ability to work independently in a fast-paced environment • Excellent computer skills • Occasional travel may be required

🏖️ Benefits

• Occasional travel may be required • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities