Associate Director, Medical Writing Job at Celcuity in Minneapolis

Title: Associate Director, Medical Writing

Location: Remote

Position Summary: We are seeking an Associate Director, Medical Writing who will report into the Executive Director of Clinical Science. You will be responsible for the creation, editing, and quality control of scientific, medical and regulatory documents. This role will also involve managing interactions with external consultants and clinical research organizations (CROs).

Responsibilities:

• Write, review, edit, proofread, verify, and manage Clinical Study Protocols, Clinical Study Reports, Investigator Brochures, NDA clinical modules, and other higher‑level regulatory documents.
• Contribute to document templates, style guides, and medical writing related SOPs.
• Conduct quality control (QC) checks to ensure accuracy, consistency, and compliance with regulatory requirements and Celcuity SOPs and Style Guide.
• Manage and coordinate communication with consultants and CROs.
• Other duties as assigned.

Qualifications:

• D., PharmD, MD/DVM, degree in biological science preferred with a minimum of 5 years of experience in oncology regulatory medical writing (MS with a minimum of 10 years relevant experience).
• 10+ years of experience preferred.
• Exceptional attention to detail.
• Proficiency in Microsoft Word; experience with Accenture Starting Point templates and add‑on toolbars is a plus.
• Scientific and medical curiosity strongly valued.

About Us: Celcuity is a clinical‑stage, publicly traded biotechnology company seeking to extend the lives of cancer patients through the development of targeted therapies for the treatment of multiple solid tumor indications. The company was founded to develop a better way to treat the cellular drivers of tumor growth. Our lead therapeutic candidate, gedatolisib, is an intravenously administered, potential first‑in‑class PI3K/AKT/mTOR (PAM) pathway inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Gedatolisib phase 3 clinical development programs are focused on the treatment of patients with HR+/HER2- ABC in the 1L and 2L settings. A Phase 1b/2 clinical trial evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is on‑going.

Celcuity is an Equal-Opportunity Employer.

Celcuity is committed to fair and equitable compensation practices, and we strive to provide employees with total compensation packages that are competitive. For this role, the anticipated base pay range is $200,000 - $230,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

The successful candidate will be eligible for an annual performance incentive bonus and a new hire equity package. Celcuity also offers various benefits offerings, including, but not limited to, medical, dental, vision insurance, 401(k) match, PTO, and paid holidays.

Notice to Recruiters/Staffing Agencies: Recruiters and staffing agencies should not contact Celcuity through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees directly. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Celcuity’s receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Celcuity and such organization and will be considered unsolicited. Celcuity will not be responsible for related fees.