AL Solutions
Senior Director of Regulatory Medical Writing
AL Solutions, Jersey City, New Jersey, us, 07305
Aramis Frost is seeking a Senior Director of Regulatory Medical Writing specializing in Oncology, to join our exclusive Biotech partner. As a key leader, you will manage and mentor a talented team of regulatory writers and serve as an SME contact for regulatory submissions and strategy. This role offers the unique opportunity to impact oncology programs that make a significant difference in patients' lives.
Have you got the right qualifications and skills for this job Find out below, and hit apply to be considered.Responsibilities
Lead and oversee the regulatory writing strategy for Oncology submissions to health authorities.Manage a team of regulatory medical writers, providing mentorship and professional development.Collaborate with cross-functional teams to align writing efforts with clinical development and regulatory strategies.Act as a primary author for crucial regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDA).Ensure compliance with regulatory requirements and industry standards for medical writing.Develop and maintain strong relationships with regulatory authorities.RequirementsAdvanced degree in Life Sciences, Medicine, or related field (PhD, MD preferred).10+ years of experience in regulatory medical writing, with a focus on Oncology.Proven leadership experience, managing teams and influencing cross-departmental initiatives.In-depth understanding of regulatory guidelines and processes for drug development.Strong communication skills, both written and verbal, with the ability to articulate complex information clearly.Exceptional project management skills, with the ability to prioritize multiple tasks effectively.Ability to work in a fast-paced environment and adapt to changing priorities.Willingness to travel occasionally to site teamBenefitsVery competitive Basic SalaryUp to 25% annual performance bonusStocks options and LTI programsHome office AllowanceAnnual company offsite holidayMental health awareness - 8 company-paid therapy sessions a yearSports Club & Gym membership100% paid medical insurance401(k) program
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Have you got the right qualifications and skills for this job Find out below, and hit apply to be considered.Responsibilities
Lead and oversee the regulatory writing strategy for Oncology submissions to health authorities.Manage a team of regulatory medical writers, providing mentorship and professional development.Collaborate with cross-functional teams to align writing efforts with clinical development and regulatory strategies.Act as a primary author for crucial regulatory documents, including Investigational New Drug (IND) applications and New Drug Applications (NDA).Ensure compliance with regulatory requirements and industry standards for medical writing.Develop and maintain strong relationships with regulatory authorities.RequirementsAdvanced degree in Life Sciences, Medicine, or related field (PhD, MD preferred).10+ years of experience in regulatory medical writing, with a focus on Oncology.Proven leadership experience, managing teams and influencing cross-departmental initiatives.In-depth understanding of regulatory guidelines and processes for drug development.Strong communication skills, both written and verbal, with the ability to articulate complex information clearly.Exceptional project management skills, with the ability to prioritize multiple tasks effectively.Ability to work in a fast-paced environment and adapt to changing priorities.Willingness to travel occasionally to site teamBenefitsVery competitive Basic SalaryUp to 25% annual performance bonusStocks options and LTI programsHome office AllowanceAnnual company offsite holidayMental health awareness - 8 company-paid therapy sessions a yearSports Club & Gym membership100% paid medical insurance401(k) program
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