Company Description

Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion.

Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career.

Recognitions

Named Science’s 2021 Top Employer

Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That’s why we were named the No. 1 company to work for in the biopharma industry in Science’s 2021 Top Employers Survey.

A Certified Great Place to Work

We believe our company is truly special, and our employees agree. In July 2022, we became Great Place to Work–certified in the U.S. for the second year in a row. In 2022, we were also listed as the No. 2 company on the Best Workplaces in BiopharmaTM List, Small and Medium, and one of the Best Workplaces in New YorkTM, which recognizes companies headquartered in NY, NJ, and CT.

Overview

The TMF Specialist is responsible for performing TMF management activities such as document filing, quality control reviews, and audit/inspection support. This role supports the cross-functional clinical trial team with document management expertise and assists in ensuring TMF completeness and compliance overseeing both the internal and any externally held Trial Master Files.

Responsibilities

Additional representative responsibilities will include, but not necessarily be limited to, the following: 

• Assists AD, TMF Operations with set-up of new studies in Insmed and/or CRO eTMF system and provides review of related documents (e.g., TMF Plan, Index, Expected Document List (EDL), etc.).
• Works with CRO and Insmed cross-functional team members on the review and submission of TMF records to eTMF.
• Assists CTAs in maintaining study TMF mailboxes to ensure timely document filing.
• Performs Quality Control of documents (paper and electronic) submitted to the TMF.
• Supports the coordination of the transfer of study-specific Trial Master Files from the CRO and assists with activities for archival of paper/electronic TMFs.
• Works closely with AD, TMF Operations on the development and standardization of TMF reporting and analytics.
• Provides input into SOP and WI development for TMF-related processes.
• Participates in Clinical Study Team meetings and provides/presents regular TMF metrics updates.
• Maintains awareness of study events, milestones, and associated documentation requirements through collaboration with Clinical Study Team.
• Supports Clinical Study Teams and designated content owners in understanding their TMF-related responsibilities, requirements, and expectations; acts as an ad-hoc member of the Clinical Study Team.
• Assists with audit/inspection readiness activities and provides support during an audit/inspection.

Qualifications

• Bachelors' degree required
• 3 years of Electronic Trial Master File management experience required.
• Veeva Vault experience a plus.
• 3 years of clinical operations or related training
• Advanced working knowledge of DIA Reference Model TMF structure
• Thorough understanding of clinical trial operations, ICH/GCP guidelines and FDA regulations
• General knowledge of medical terminology
• Proven ability to work with a high level of integrity, accuracy, and attention to detail
• Strong technical/analytical skills to identify and solve problems
• Self-motivated, assertive, and self-confident with the ability to act with urgency and passion
• Experience with FDA, PMDA, MHRA inspections is preferred
• Must have excellent communication skills (verbal and written)
• Highly organized with a strong attention to detail, clarity, accuracy and conciseness

Travel Requirements

Up to 10% travel.

Additional Information

Insmed Incorporated is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at TotalRewards@insmed.com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

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.