Insmed Incorporated

Document Control Specialist

ID
2019-1248

Company Description

About Insmed!

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

About the role!

This position is responsible for the accurate management and safeguarding of documentation generated by Technical Operations, including contractors. This includes, but is not limited to, the creation and maintenance of templates, formatting, revising and management of controlled documents. In addition, the document specialist will assist in the dissemination of documents to outside organizations.

Responsibilities

Following is a list of essential duties, functions and responsibilities, including key aspects of the role; whether performed daily, weekly, monthly, or annually, and any that occur at irregular intervals.

  • Format regulatory document sections consistent with other departments assuring ready to publish state.
  • Prepare, operate and update Document Control Procedures in line with the Insmed’s Documents Management System.
  • Assist with the maintenance and alignment of Technical Operations documentation, change controls, investigations, SOP’s and workflows, ensuring alignment with company documentation structure.
  • Perform detailed review of change controls/investigations for accuracy, robustness, and completeness. Follow-ups to ensure timelines are met for Technical Operations deliverables.
  • Ensure all documentation is formatted correctly. Formatting may include creating templates, fonts and style, pagination and numbering and any other activities required to achieve document requirements. Contributes to continuous improvement of document templates.
  • Disseminate documents from outside partners to the appropriate internal counterpart and track to follow through to completion.
  • Maintains master documents and records (both hardcopy and electronic) as required by applicable regulations such that required documentation is retrievable and files are accurate, complete and well organized.
  • Recommends improvements in current document control systems, provides written procedures, reviews and comments on related documentation procedures, and ensures their proper implementation.
  • Present/discuss pending and/or delayed change actions at monthly sub-team meetings for each Insmed’s drug programs.
  • Identify causes of documentation and change control process rework/delay and implement actions to streamline process.

Qualifications

Knowledge & Experience           

  • Minimum of 3 years’ document control experience, preferably in the pharmaceutical/biotech industry
  • Familiar with e-Document management systems, VEEVA
  • Knowledge of eCTD format

Qualifications   

  • BA/BS or equivalent relevant experience
  • Must have excellent communication skills (verbal and written).
  • Understand good documentation practices.
  • Utilize electronic systems to track and manage information
  • Highly organized and self-motivated with a strong attention to detail.
  • Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).

 

Other (if applicable):     

  • Must successfully exhibit Insmed’s five (5) core corporate values: Passion, Accountability, Collaboration, Integrity and Respect; along with any other position specific competencies
  • Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace
  • Individuals must be able to work independently

Additional Information

We offer a competitive benefits package that includes healthdentalvisionwellness programs, employee discount programs, 401k and more. This position is also bonus eligible.

 

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.

 

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