MEET RECRUITMENT LIMITED
Associate/Director, Medical Writing (Regulatory/Clinical - ON SITE)
MEET RECRUITMENT LIMITED, San Francisco, California, United States, 94199
Meet is currently partnered with a cutting-edge biotechnology company based in the San Francisco Bay Area, dedicated to advancing innovative therapies that address significant medical needs. They are seeking a highly skilled and experienced an Associate Director OR Director, Medical Writing to lead their Medical Writing team. You will play a crucial role in guiding and overseeing the creation of clinical and regulatory documents essential for advancing their pipeline of therapies.
If the following job requirements and experience match your skills, please ensure you apply promptly.Key Responsibilities:Provide strategic leadership and management oversight to the Medical Writing team.Direct the planning, preparation, and finalization of a wide range of clinical and regulatory documents, including but not limited to Clinical Study Reports (CSRs), Investigator's Brochures (IBs), study protocols, safety reports, and New Drug Applications (NDAs).Ensure compliance with industry standards, regulatory requirements, and internal guidelines for all documents produced by the team.Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Pharmacovigilance, and Quality Assurance, to support regulatory submissions and responses to regulatory agencies.Mentor and develop staff within the Medical Writing team, fostering a culture of excellence, teamwork, and continuous learning.Therapy areas: oncology, metabolism, psychiatry, neurology, addiction.Qualifications:PhD, PharmD, or MD degree in a relevant scientific discipline.Minimum of 10 years of experience in medical writing within the biotechnology or pharmaceutical industry, with a focus on clinical and regulatory documents.Proven expertise in preparing major regulatory submissions (e.g., NDAs, BLAs) and supporting documents.Thorough understanding of ICH guidelines, GCP, and other relevant regulations and guidelines.Strong leadership skills with experience in managing and developing a team of medical writers.Ability to come into a Bay Area location on a hybrid basis.Full job description and company details are available upon application, apply below. This position is being dealt with by Carly Tappeto at Meet, email directly at carly.tappeto@peoplewithchemistry.com to discuss further and in confidence.
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If the following job requirements and experience match your skills, please ensure you apply promptly.Key Responsibilities:Provide strategic leadership and management oversight to the Medical Writing team.Direct the planning, preparation, and finalization of a wide range of clinical and regulatory documents, including but not limited to Clinical Study Reports (CSRs), Investigator's Brochures (IBs), study protocols, safety reports, and New Drug Applications (NDAs).Ensure compliance with industry standards, regulatory requirements, and internal guidelines for all documents produced by the team.Collaborate closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Pharmacovigilance, and Quality Assurance, to support regulatory submissions and responses to regulatory agencies.Mentor and develop staff within the Medical Writing team, fostering a culture of excellence, teamwork, and continuous learning.Therapy areas: oncology, metabolism, psychiatry, neurology, addiction.Qualifications:PhD, PharmD, or MD degree in a relevant scientific discipline.Minimum of 10 years of experience in medical writing within the biotechnology or pharmaceutical industry, with a focus on clinical and regulatory documents.Proven expertise in preparing major regulatory submissions (e.g., NDAs, BLAs) and supporting documents.Thorough understanding of ICH guidelines, GCP, and other relevant regulations and guidelines.Strong leadership skills with experience in managing and developing a team of medical writers.Ability to come into a Bay Area location on a hybrid basis.Full job description and company details are available upon application, apply below. This position is being dealt with by Carly Tappeto at Meet, email directly at carly.tappeto@peoplewithchemistry.com to discuss further and in confidence.
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