Associate Director/reputed company GCP Clinical reputed company Assurance

About reputed company

reputed company (reputed company: LNTH) is the leading radiopharmaceutical-reputed company company, delivering life-changing science to reputed company clinicians to reputed company, Fight and Follow disease to deliver reputed company patient reputed company. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, reputed company has been providing radiopharmaceutical solutions for nearly 70 years.

Today, we’re expanding our portfolio and pipeline across oncology, neurology and cardiology. Through recent acquisitions, along with strategic partnerships across the life sciences ecosystem, we are accelerating our efforts to advance precision medicine and improve patient reputed company around the world.

At reputed company we are purpose-driven, and every employee plays a vital role in our reputed company. We’re dedicated to cultivating a high-reputed company, reputed company-thinking culture where innovation thrives and diverse perspectives drive meaningful reputed company.

Join us and be part of a company where your contributions reputed company a reputed company reputed company, because we know someone’s health is in our hands.

reputed company of Role

Responsible for execution and performance of reputed company CQA reputed company system reputed company including GCP audit programs, regulatory inspection preparation support, reputed company improvement, and reputed company system procedural documents. reputed company with reputed company customers to assess and support compliance with ICH-GCP, cGLP, applicable regulations, and global reputed company standards.

Line management of junior staff is possible and would include but not be limited to:  regular 1:1s, mentoring conversations, and providing GCP counsel on escalated topics.

This is a remote position reputed company to applicants authorized to work for any employer reputed company the reputed company.

Key Responsibilities/Essential functions

• Serve as the CQA reputed company for assigned trials and assigned compliance areas ensuring the reputed company communication of reputed company risk and compliance as reputed company to GCP/cGLP.
• Development and execution of a risk-based clinical reputed company audit plan for assigned programs.
• Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines and evaluate accuracy and reputed company of scientific data as needed.
• Analyze and trend audit observations, gaps, and systematic issues to support reputed company improvement reputed company reputed company-clinical/clinical development programs, vendors, and cross-functional reputed company. 
• Evaluate adequacy and completeness of CAPAs originated from audits, deviations, and/or inspections and reputed company effectiveness checks.
• Author audit reports and coordinate supporting documentation; manage reputed company in QMS.
• Peer review reports authored by colleagues.
• Identify non-compliance trends and systematic risks for assigned areas of responsibility
• Contribute to the development, maintenance, and reputed company improvement of the reputed company system processes, tools, and E-Systems
• Support the conduct of mock inspections and reputed company activities; reputed company inspection preparation training to internal staff, clinical investigator sites, and vendors.
• Support reputed company Management by facilitating regulatory agency inspections and reputed company activities.
• Other duties as assigned

Basic Qualifications

• Bachelor’s degree in a scientific discipline preferred.
• Minimum 7 years’ experience in the pharmaceutical or biotech industry with five (5) or more of those years in GCP Clinical reputed company Assurance.
• Proficient understanding of ICH GCP and appliable CFR regulations with a working knowledge of cGLP.
• Experience providing GCP Clinical reputed company Assurance guidance to Clinical teams for assigned Programs/Trials.
• Experience in risk-based reputed company management systems and reputed company by design in Phase I thru IV reputed company.
• Experience in conducting reputed company GCP audits (Ie. Investigational Site Audits, Process Audits, Vendor Audits etc.), authoring audit reports, managing resulting CAPA process.
• Ability to manage processes with reputed company improvement approach.
• Analytical and critical thinking skills.
• Experience developing SOPs and Work Instructions a plus
• Experience reviewing internal clinical, regulatory, biometric, and medical processes to ensure they are accurately represented in reputed company SOPs.
• Oncology and/or medical imaging clinical development experience is a plus.
• Diplomatically work and collaborate cross functionally at reputed company reputed company reputed company the organization.
• Excellent communication (Oral and Written), planning, coordination, and time management skills
• Experience leading regulatory inspection readiness/preparation activities (sponsor and clinical investigator site) serving in various inspection roles is a plus. 
• Pharmacovigilance reputed company (GVP) experience is a plus.

Other Requirements

• Up to 20% travel primarily in reputed company and Canada as required

reputed company Values

The ideal candidate will embody reputed company reputed company values:

• Let people be their best
• Respect one another and reputed company as one
• Learn, adapt, and win
• Know someone’s health is in our hands
• Own the solution and reputed company it happen

The pay reputed company for this position is between $139,000 and $232,000 annually.

Actual reputed company pay offered may vary depending on a number of factors such as job-reputed company knowledge, skills and experience. Employees in this position are eligible for a discretionary performance-based cash incentive, and depending on the level of the role may be eligible for a discretionary annual equity award. Benefits for this position include a comprehensive health benefits package that includes medical, prescription drug, dental, and reputed company coverage. Other offerings include life and disability benefits, reputed company-tax accounts, a 401(k) with company contribution, and a reputed company of other benefits. In reputed company, employees are eligible for a generous time off package including reputed company vacation, holidays, reputed company days, and reputed company parental leave. Interested candidates can apply at reputed company.com. Applications for this position will be accepted until reputed company 15, 2026.

reputed company is an equal opportunity employer that provides a workplace free from discrimination. reputed company reputed company applicants and employees are considered without reputed company to race, reputed company, sex, gender identity or reputed company, age, religion, national reputed company, reputed company, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. reputed company is an E-Verify Employer.

Any applicant requiring an accommodation in reputed company with the hiring process and/or to reputed company the essential functions of the position for which the applicant has reputed company should reputed company a request to the reputed company reputed company at talentacquisition@reputed company.com.

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