Associate Director, Medical Writing

About the company

The company Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At the company, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. The company’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence.

The company’s team is inspired to touch and help change lives through the company’s clinical studies in the field of oncology. The company has multiple global Phase 3 clinical studies, including:

Non-small Cell Lung Cancer (NSCLC)

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HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

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HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC.

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HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

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HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). The company is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.

Overview of Role

The Associate Director, Medical Writing will collaborate with colleagues to produce high-quality, strategically aligned documents supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements.

​ Role and Responsibilities

• Prepare, edit, and finalize clinical/regulatory documents, including protocols/protocol amendments, clinical study reports (CSRs), Investigator’s Brochures, briefing documents, Module 2 clinical summary documents, and other regulatory submissions as needed

• Interact with document authors, contributors, and reviewers (including members of Biometrics, Clinical Operations, Clinical Development, Drug Safety, and Regulatory Affairs) to acquire necessary input into documents

• Manage the document review process and schedule and conduct meetings to ensure documentation timelines are achieved

• Manage medical writing timelines for assigned documents to ensure on-time deliverables that meet business needs

• Facilitate comment resolution and adjudication with authors, reviewers, and project teams

• Participate in the refinement of medical writing processes, SOPs, work instructions, templates, and style and content guides to ensure efficient preparation of high- quality medical writing deliverables

Experience, Education and Specialized Knowledge and Skills

• BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred

• 8+ years of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience writing clinical study protocols, clinical study reports, investigator’s brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents.

• Knowledge of oncology disease areas preferred

• Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines

• Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness

• Excellent attention to detail, multitasking, prioritization, and flexibility

• Excellent communication skills with proven ability to interact in a cross-functional environment

• Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas

• Proficiency in use of MS Office applications, Adobe Acrobat, electronic document management systems, and templates.

• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities

• Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal direction

• Ability to think strategically, be resourceful, and lead with minimal direction

This is the pay for this position

Pay Transparency

$169,000 — $198,000 USD

Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.

The company does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact the company’s Talent Acquisition team at  [link for members]  to obtain prior written authorization before referring any candidates to the company.

The company Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.