Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have)

Overview

Senior principal medical writer role authoring and managing global regulatory submission documents, including ISE, ISS and Clinical Overview documents.

What you'll do

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and client authoring standards, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines with study/project teams as necessary and communicating with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes needed to complete regulatory documents.
• Review other documents associated with assigned projects, such as protocols and statistical analysis plans, as appropriate.
• Participate in cross-functional process improvement initiatives.
• Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents.
• Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

What you'll need

• Bachelor's degree.
• At least 5 years of medical writing experience in the biopharmaceutical/CRO industry, or comparable experience within clinical or preclinical development.
• Proficiency in organizing and communicating clinical information with minimal oversight.
• Strong organizational, time management, and project management skills.
• Strong verbal, written, and interpersonal communication skills to work effectively in a team environment.
• Proficient understanding and knowledge of global regulatory requirements.
• Proficient in MS Word.
• Experience with an electronic document management system and templates.

Nice to have

• Oncology experience.
• Advanced degree in a relevant scientific, clinical or regulatory field.
• Knowledge of therapeutic areas in all phases of clinical development.

Details

• Location: USA, Delaware, remote.
• Salary range: $114,000.00 - $210,900.00.
• Benefits may include a company car or car allowance, medical, dental and vision health benefits, company match 401k, Employee Stock Purchase Plan eligibility, commissions/bonus eligibility, and flexible paid time off and sick time.