Director, Medical Writing

Our Mission

To build a viable long-lasting health care organization that assumes full responsibility for designing, developing, trial enrollment, regulatory approval and commercializing patient, physician, caregiver, payor, and societal friendly medicinal therapy intended to improve quality of life, increase potential duration of life and resolve serious medical healthcare needs. To identify and control promising product candidates based on exceptional scientific development and administrational expertise, develop our products in a rapid, cost-efficient manner and to pursue commercialization and/or development partners when and where appropriate.

We will accomplish this by building a team of world class scientists and business administrators that apply themselves to this mission. Team Summit exists to strategize and execute a path forward in medicinal therapeutic health care that places us in a top market share leadership position. Team Summit assumes responsibility for stimulating continuous expansion of knowledge, ability, capability and wealth for all involved stakeholders.

Overview Of Role

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
  
  

Experience, Education And Specialized Knowledge And Skills

• 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
  
  

The pay range for this role is $209,000 to $230,000 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. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

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.