Senior Regulatory Compliance Specialist, Clinical Operations

1 week ago


BalaCynwyd, United States Larimar Therapeutics Full time
Job Overview

Larimar Therapeutics Inc., a clinical-stage biotechnology company, seeks an experienced Senior Regulatory Compliance Specialist to join its Clinical Operations team. This role will provide critical support in ensuring compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations.

Responsibilities
  • Develop and execute risk-based audit strategies for Clinical and Pharmacovigilance programs.
  • Oversee the execution of external audits of GCP/GVP vendors and investigator sites, as well as internal GCP/GVP audits.
  • Collaborate with Quality representatives at Contract Research Organizations (CROs) and service providers to ensure quality agreements and study plans are developed and implemented.
  • Participate in relevant clinical and safety-related team meetings.
  • Support the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures, including SOPs and risk assessment tools.
Requirements

A Bachelor's degree in life sciences is required, along with a minimum of 8+ years of experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment.

The ideal candidate will possess thorough knowledge of GxP systems, quality principles, and GCP/GVP regulations, as well as experience hosting GCP regulatory inspections.

Benefits

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan, including 401K, and a flexible PTO policy.

Estimated salary: $140,000 - $170,000 per year.



  • Bala Cynwyd, United States Pennsylvania Medicine Full time

    Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines. Today at Penn...

  • Associate Director

    4 days ago


    Bala-Cynwyd, United States Larimar Therapeutics Inc Full time

    Job DescriptionJob DescriptionThe Company:Larimar Therapeutics Inc. (Larimar) is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a...


  • Bala Cynwyd, United States Penn Medicine Full time

    Description Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines. Today...


  • Bala Cynwyd, United States Penn Medicine Full time

    **Description** Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all...


  • Bala Cynwyd, United States Pennsylvania Medicine Full time

    Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.Today at Penn...


  • Bala Cynwyd, United States Pennsylvania Medicine Full time

    Penn Medicine is dedicated to our tripartite mission of providing the highest level of care to patients, conducting innovative research, and educating future leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across all disciplines.Today at Penn...


  • Bala-Cynwyd, United States Larimar Therapeutics Full time

    Job DescriptionJob DescriptionDescription:The Company:Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is...


  • Bala-Cynwyd, United States Larimar Therapeutics Full time

    Job DescriptionJob DescriptionDescription:The Company:Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is...


  • Bala Cynwyd, United States Pennsylvania Medicine Full time

    Penn Medicine, a leading academic medical center, is dedicated to delivering exceptional care to patients. Our team of healthcare professionals collaborates across disciplines to drive innovative research and educate future leaders in medicine.As a full-time LPN Clinical Scheduling Operations Assistant, you will play a critical role in overseeing clinical...

  • Operations Specialist

    3 months ago


    Bala Cynwyd, United States Aveanna Healthcare LLC Full time

    OverviewPosition OverviewThe Operations Specialist - Onboarding/Employee Records is responsible for providing top level customer service to internal and external clients as it relates to branch location's clinical operational support activities. Essential Job Functions Personnel Activities: o Participates in location recruiting activities, including...

  • Nursing Supervisor

    6 months ago


    Bala Cynwyd, United States LCB Senior Living Full time

    Job Details Description **FULL TIME DAYS**PREMIUM SALARY**SCHEDULED MON-FRI** LCB Senior Living is hiring a  Nursing Supervisor  at The Residence at Bala Cynwyd! **Must have Nursing License** Benefits starting day 1! Health Vision Dental Life Insurance 401k Paid time off (after grace period) Opportunity for Growth ...


  • Bala-Cynwyd, Pennsylvania, United States Sardi's Pollo A La Brasa Full time

    We're seeking a skilled Restaurant Operations Specialist to support our General Manager in driving restaurant profitability, staffing, people development, product quality, customer satisfaction, image, and culture. In the absence of the General Manager, the Restaurant Operations Specialist will perform all managerial duties, ensuring seamless operations and...


  • Bala Cynwyd, United States Ambulatory Surgery Center of Bala Cynwyd Full time

    OverviewThe following information provides an overview of the skills, qualities, and qualifications needed for this role.* Looking for an enthusiastic & motivated registered nurse to join our fast growing surgery center.* With a positive attitude and an eagerness to learn there is lots of room for advancement.* You will be engaging Orthopedic, Spine and Pain...


  • Bala-Cynwyd, Pennsylvania, United States Pennsylvania Medicine Full time

    Job Summary:As a key member of the Penn Medicine Medical Group Regional Practices team, the Director of Physician Compensation will play a vital role in shaping the organization's compensation strategy. Reporting to the SVP, PMMG Regional Practices, this individual will lead a team of compensation and finance professionals, providing strategic guidance on...


  • Bala Cynwyd, United States BAYADA Home Health Care Full time

    About Us: BAYADA Home Health Care is a leading provider of home health care services, committed to delivering high-quality care to our clients.Salary: $40,000 - $60,000 per year, depending on experience.Job Description: As a Per Diem Fitness Specialist, you will lead scheduled group exercise classes for residents in Senior Living Communities. You will design...


  • Bala-Cynwyd, United States LHH Recruitment Solutions Full time

    Job DetailsLHH Recruitment Solutions is seeking a detail-oriented Payroll Analyst/Auditor with strong proficiency in Microsoft Excel. This role offers a hybrid work schedule, following onsite training. The successful candidate will have 2 years of experience in accounting, payroll, or financial analysis, with excellent client-facing and communication...


  • Bala-Cynwyd, United States Larimar Therapeutics Full time

    Job DescriptionJob DescriptionDescription:The Company:Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is...


  • Bala Cynwyd, United States Larimar Therapeutics Full time

    Job Type Full-time Description The Company: Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a...


  • Bala-Cynwyd, United States Larimar Therapeutics Full time

    Job DescriptionJob DescriptionDescription:The Company:Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is...


  • Bala-Cynwyd, United States Larimar Therapeutics Full time

    Job DescriptionJob DescriptionDescription:The Company:Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is...