Director of Regulatory Medical Writing

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Director of Regulatory Medical Writing

AL Solutions

Lexington, massachusetts

AL Solutions is seeking a highly motivated Director of Regulatory Medical Writing for a major Biotech company specializing in Oncology. In this leadership role, you will be responsible for overseeing a team of regulatory writers while ensuring the quality and accuracy of pivotal documents required for regulatory submissions. Your expertise will directly contribute to advancing Oncology programs that are set to make a significant impact on patient outcomes.

Key Responsibilities:

Lead the regulatory writing team, mentoring and guiding members to enhance their skills and ensure high-quality output.
Take charge of the overall regulatory writing strategy for Oncology submissions, ensuring compliance with health authority guidelines.
Collaborate with cross-functional teams, including clinical, safety, and medical affairs, to produce critical documents such as Clinical Study Reports (CSRs), Investigational New Drug (IND) applications, and New...

Not Specified

Associate Director of Regulatory Medical Writing

AL Solutions

Redwood City, california

Aramis Frost is partnering with a leading Biotech specializing in Oncology to find an Associate Director of Regulatory Medical Writing. In this pivotal role, you will oversee the regulatory writing strategy and contribute significantly to the development of cutting-edge oncology therapies. You will work closely with cross-functional teams to ensure timely and accurate submissions to regulatory authorities.

Key Responsibilities

Lead the preparation and review of complex regulatory documents, including INDs, NDAs, and clinical study reports.
Collaborate with project teams to develop writing strategies that align with clinical and regulatory objectives.
Mentor and guide team members in best practices for regulatory writing and compliance.
Maintain up-to-date knowledge of regulatory guidelines and industry trends specific to oncology.
Engage with regulatory agencies as needed to facilitate the submission process.

Full-time

Senior Director of Regulatory Medical Writing

AL Solutions

Jersey City, new jersey

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.

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...

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