Senior Medical Writer

Company Description

Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.

Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference. 

Overview

The successful candidate is responsible for the complete preparation, including but not limited to, the writing, reviewing and editing of protocols and protocol amendments, Investigator’s Brochures (IBs) and IB updates, clinical study reports (CSRs), briefing books, and Summary Modules for Regulatory Submissions. As a content expert, this position has a significant understanding of regulatory requirements and ICH guidelines (including E3 and E6), and knowledge of document management systems.

Responsibilities

• Author clinical regulatory documents with minimal input from functional area experts.
• Lead the writing activities, including management of document review cycles and cross-functional collaboration with clinical development, biostatistics, clinical operations, pharmacovigilance, regulatory, project management, and quality assurance.
• Provide input on cross-functional deliverables, as appropriate, including review of key contributing documents, such as the mock/shell Table, Figures, and Listings (TFLs) and Statistical Analysis Plan.
• Participate in the planning and negotiation of timelines.
• Serve as a subject matter expert, representing Medical Writing on cross-functional teams.

Qualifications

• Minimum 5 years of experience with a Master’s of Science degree, PharmD, PhD, or MD preferred; or Minimum 7 years of experience with a Bachelor's degree in Life Sciences or related field.
• Regulatory medical writing experience is required; experience in Infectious Diseases or Pulmonary Disorders, or related areas is highly preferred.
• Must demonstrate a high-quality writing style in the English language and have the ability to independently interpret and present scientific and clinical data, and to understand statistical methods and analysis plans.
• Exceptional organizational and project planning skills.
• Strong interpersonal skills and the ability to negotiate and influence in a cross-functional environment to achieve results.
• Must be able to manage multiple and varied programs with competing and aggressive  timelines, prioritize activities, and be able to succeed in a fast-paced environment.
• Dynamic, self-starter with strong influential skills and be adaptable to change.
• Understanding of regulatory requirements and ICH guidelines (including E3 and E6), and knowledge of document management systems.
• Familiar with style rules from the American Association Manual of Style, 10th Edition.
• Must demonstrate Insmed values: Collaboration, Accountability, Passion, Respect, Integrity
• Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace

Additional Information

Insmed is an Equal Opportunity Employer and will judge all applicants based on their qualifications for the job, without regard to race, color, sex, religion, national origin, age, disability or any other characteristics protected by applicable federal, state or local law.

Unsolicited resumes from agencies should not be forwarded to Insmed. Insmed will not be responsible for any fees arising from the use of resumes through this source. Insmed will only pay a fee to agencies if a formal agreement between Insmed and the agency has been established. The Human Resources department is responsible for all recruitment activities; please contact us directly to be considered for a formal agreement.

Please note that we review every submission and we will keep all submissions on file for six months. Insmed is an Equal Opportunity Employer.

All your information will be kept confidential according to EEO guidelines