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Biotechnology: Clinical Trials and Regulatory Affairs Job Description Templates

  1. Clinical Research Associate (CRA)

Title: Clinical Research Associate (CRA) (Biotechnology) Location: [Company Location] Employment Type: Full-time

Job Description: We are seeking a motivated and detail-oriented Clinical Research Associate (CRA) to join our clinical research team. The CRA will be responsible for monitoring and managing clinical trials, ensuring compliance with protocols, regulations, and study timelines. This role offers an exciting opportunity to contribute to the development of innovative biotechnological therapies and treatments.

Responsibilities:

  • Conduct site qualification, initiation, monitoring, and close-out visits for clinical trials according to protocol requirements and regulatory guidelines.
  • Ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulations throughout the conduct of clinical trials.
  • Perform source data verification, data review, and query resolution to ensure the accuracy and integrity of clinical trial data.
  • Communicate effectively with investigators, site staff, and study sponsors to facilitate study conduct, resolve issues, and ensure timely completion of study milestones.
  • Prepare and maintain study documentation, including study plans, monitoring reports, and regulatory submissions, in accordance with regulatory requirements and company standards.

Qualifications:

  • Bachelor’s or master’s degree in life sciences, nursing, or a related field.
  • Prior experience as a clinical research associate (CRA) or clinical trial monitor in the biotechnology or pharmaceutical industry.
  • Knowledge of clinical trial regulations, GCP guidelines, and regulatory requirements, including FDA regulations and ICH guidelines.
  • Strong organizational and time management skills, with the ability to prioritize tasks and meet deadlines.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
  1. Regulatory Affairs Specialist

Title: Regulatory Affairs Specialist (Biotechnology) Location: [Company Location] Employment Type: Full-time

Job Description: We are looking for a dedicated and knowledgeable Regulatory Affairs Specialist to join our regulatory affairs team. The Regulatory Affairs Specialist will be responsible for managing regulatory submissions, ensuring compliance with applicable regulations, and supporting product registration activities. This role offers an exciting opportunity to contribute to the successful commercialization of biotechnological products and therapies.

Responsibilities:

  • Prepare and submit regulatory filings, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
  • Review and interpret regulatory guidelines and requirements to ensure compliance with FDA, EMA, and other regulatory authorities.
  • Coordinate regulatory submissions and interactions with regulatory agencies, including responding to requests for information and participating in meetings.
  • Support product development teams in the planning and execution of regulatory strategies and risk assessments.
  • Maintain regulatory documentation, records, and databases in accordance with regulatory standards and internal procedures.

Qualifications:

  • Bachelor’s or master’s degree in regulatory affairs, life sciences, pharmacy, or a related field.
  • Prior experience in regulatory affairs within the biotechnology or pharmaceutical industry.
  • Knowledge of FDA regulations, ICH guidelines, and international regulatory requirements.
  • Strong attention to detail, organizational skills, and the ability to manage multiple projects simultaneously.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively in cross-functional teams.
  1. Clinical Data Manager

Title: Clinical Data Manager (Biotechnology) Location: [Company Location] Employment Type: Full-time

Job Description: We are seeking an experienced and detail-oriented Clinical Data Manager to join our clinical research team. The Clinical Data Manager will be responsible for managing clinical trial data, ensuring its accuracy, completeness, and integrity, and supporting data analysis and reporting activities. This role offers an exciting opportunity to contribute to the advancement of biotechnological therapies and treatments.

Responsibilities:

  • Develop and implement data management plans (DMPs) for clinical trials, including data collection, validation, and cleaning procedures.
  • Oversee data collection, entry, and quality control activities to ensure the accuracy and integrity of clinical trial data.
  • Perform database design, configuration, and validation activities using electronic data capture (EDC) systems or other data management tools.
  • Generate and review data listings, summary tables, and data listings for clinical study reports and regulatory submissions.
  • Collaborate with cross-functional teams, including biostatistics, clinical operations, and regulatory affairs, to support data analysis and reporting activities.

Qualifications:

  • Bachelor’s or master’s degree in biostatistics, epidemiology, computer science, or a related field.
  • Previous experience as a clinical data manager in the biotechnology, pharmaceutical, or contract research organization (CRO) industry.
  • Knowledge of clinical trial data management principles, practices, and regulations, including CDISC standards and FDA guidance.
  • Proficiency in using clinical data management systems (CDMS) and statistical analysis software, such as SAS or R.
  • Strong analytical skills, problem-solving abilities, and attention to detail.
  1. Regulatory Compliance Officer

Title: Regulatory Compliance Officer (Biotechnology) Location: [Company Location] Employment Type: Full-time

Job Description: We are seeking a dedicated and experienced Regulatory Compliance Officer to join our regulatory affairs team. The Regulatory Compliance Officer will be responsible for ensuring compliance with regulatory requirements, developing and implementing compliance programs, and conducting audits and assessments to identify and mitigate compliance risks. This role offers an exciting opportunity to contribute to the successful commercialization of biotechnological products and therapies.

Responsibilities:

  • Develop, implement, and maintain regulatory compliance programs and policies to ensure adherence to FDA, EMA, and other regulatory requirements.
  • Conduct internal audits and assessments to evaluate compliance with regulatory standards, quality systems, and company policies and procedures.
  • Review and assess regulatory changes and updates to determine their impact on company operations and compliance obligations.
  • Provide guidance and support to cross-functional teams on compliance-related matters, including product development, manufacturing, and quality assurance.
  • Prepare and submit regulatory filings, reports, and submissions in compliance with regulatory requirements and deadlines.

Qualifications:

  • Bachelor’s or master’s degree in regulatory affairs, life sciences, or a related field.
  • Previous experience in regulatory compliance within the biotechnology or pharmaceutical industry.
  • Knowledge of FDA regulations, EU directives, and international regulatory requirements.
  • Strong understanding of quality management systems, GMP regulations, and regulatory submission processes.
  • Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.

These comprehensive job descriptions can be customized to meet the specific requirements of your company and the roles you are hiring for in the biotechnology sector.

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