Associate Director, Medical Writing

Summittherapeutics; Princeton (NJ); On-site; USD 175,000 - 190,000; Full time

Job summary

An established industry player is seeking an Associate Director of Medical Writing to lead the creation of high-quality regulatory documents for clinical development. This role is pivotal in ensuring compliance with US and international regulations while collaborating with cross-functional teams. The ideal candidate will have extensive experience in regulatory writing, particularly in clinical study protocols and reports, and possess excellent writing and communication skills. Join a dynamic environment where your expertise will directly impact the success of innovative therapies. This is an exciting opportunity for a driven professional looking to make a significant contribution in the pharmaceutical sector.

Qualifications

• 8+ years of regulatory medical writing experience in the pharmaceutical industry.
• Ability to write and edit complex material with accuracy and clarity.

Responsibilities

• Prepare and edit clinical/regulatory documents for compliance with regulations.
• Manage the document review process and ensure timelines are met.

Skills

Regulatory Medical Writing

Excellent Writing Skills

Attention to Detail

Communication Skills

Critical Analysis

Multitasking

Flexibility

Education

BA/BS in Scientific Field

PhD, PharmD, or MS (Preferred)

Tools

MS Office Applications

Adobe Acrobat

Electronic Document Management Systems

Job description

Job Title: Associate Director, Medical Writing

Department: Medical Writing

*Relocation support will be considered for this role

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 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 development/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.

The pay range for this role is $175,000-$190,000 annually. 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.