Associate Director, Clinical Research / Clinical Research Manager
February 14, 2023
Associate Clinical Director, Onc / Global
- This job was published on February 14, 2023
- Start date - Asap
- End date - Without end
- Location - Northeast
- Full-Time
Responsibilities
- Assist in the development and execution of the clinical portions of a product development plan to ensure the project is progressing in a timely and scientifically sound manner.
- Ensure the preparation of all required documents for approval adheres to Good Clinical Practice (GCP), Clinical Operating Guidelines, and Standard Operating Procedures (SOPs).
- Collaborate with various departments to define the timing of discussions with regulatory bodies such as the FDA.
- Manage the format and submission of the clinical New Drug Application (NDA) or other relevant submissions to regulatory authorities.
- Oversee the quality and timeliness of clinical documentation, ensuring they meet the necessary regulatory standards.
Required Skills
- Strong understanding of Good Clinical Practice (GCP) and regulatory requirements related to clinical trials and submissions.
- In-depth knowledge of clinical development processes and product development timelines.
- Experience in preparing and submitting clinical documentation, including New Drug Applications (NDA) and other regulatory submissions.
- Proficiency in clinical operating guidelines and standard operating procedures.
- Strong attention to detail to ensure the accuracy and compliance of all clinical documents.
Preferred Skills
- Experience working directly with regulatory bodies like the FDA on clinical trial submissions.
- Ability to liaise effectively with cross-functional teams (e.g., regulatory affairs, quality assurance, clinical operations) to drive the product development plan forward.
- Familiarity with industry-specific software or tools used for clinical documentation and regulatory submissions.
- Expertise in managing clinical trial timelines and coordinating discussions with stakeholders.
- Advanced knowledge of clinical trial design and regulatory submission formats.
Soft Skills
- Strong communication skills to effectively liaise with internal teams and regulatory authorities.
- Problem-solving abilities to handle regulatory challenges and ensure timely resolution.
- Attention to detail to ensure high-quality, compliant documentation.
- Organizational skills to manage multiple priorities and deadlines.
- Ability to work collaboratively in a fast-paced and dynamic environment.
- Adaptability to changes in regulatory requirements and product development strategies.
Qualifications
- Bachelor’s degree in life sciences, pharmacy, medicine, or a related field (Master’s or Doctorate preferred).
- Proven experience in clinical operations, product development, or regulatory affairs within the pharmaceutical or biotechnology industry.
- Familiarity with clinical trial design, regulatory guidelines, and industry standards.
- Certification in clinical research or regulatory affairs (e.g., ACRP, RAC) is a plus.
- Previous experience working with the FDA and other regulatory bodies is highly desirable.
Benefits
401(k), Dental insurance
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Apply for: Associate Clinical Director, Onc / Global
- Start date - Asap
- End date - Without end
- Location - Northeast
- Full-Time
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