Director, Medical Writing
Director, Medical Writing
Summit Therapeutics, Inc.
United States
See who Summit Therapeutics, Inc. has hired for this role
Pay found in job post
Retrieved from the description.
Base pay range
The 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
- Develop and 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
- BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred
- 10+ 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
Summit 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 Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.
-
Seniority level
Director -
Employment type
Full-time -
Job function
Strategy/Planning and Information Technology -
Industries
Biotechnology Research
Referrals increase your chances of interviewing at Summit Therapeutics, Inc. by 2x
See who you knowGet notified about new Medical Director jobs in United States.
Sign in to create job alertSimilar jobs
People also viewed
-
Director Medical Affairs
Director Medical Affairs
-
Assistant Director, Medical Affairs
Assistant Director, Medical Affairs
-
Interim Chief Medical Officer
Interim Chief Medical Officer
-
Senior Director, Medical Strategy
Senior Director, Medical Strategy
-
Associate Director Medical Education
Associate Director Medical Education
-
Chief Medical Officer - Outpatient Community Health Services
Chief Medical Officer - Outpatient Community Health Services
-
Medical Director
Medical Director
-
Senior Medical Director
Senior Medical Director
-
Care Navigation, Medical Director
Care Navigation, Medical Director
-
Director Clinical Operations
Director Clinical Operations
Similar Searches
Explore collaborative articles
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
Explore More