Manager, Document Management and Clinical Quality Control | BioNJ Talent Services

Manager, Document Management and Clinical Quality Control

Contact Information
Contact Name: 
Insmed
Organization Name: 
Insmed
Position Location: 
Bridgewater
Company Profile: 

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.

Job Description:

SUMMARY:

The primary responsibilities of this position are to check the quality of clinical documents including but not limited to, protocols, Investigator Brochures (IBs), clinical study reports (CSRs), 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 basic knowledge of document management systems.

This position reports to the Senior Director, Medical Writing and is located at our Bridegewater,New Jersey headquarters location.

RESPONSIBILITIES:
•Provides formatting, quality, stylistic and publishing support to Medical Writing and other functions (eg, TMCP) as needed; Interacts with various departments for Document Quality (eg. Clinical Operations, Regulatory Operations, Clinical and TMCP)
•Checks clinical documents for appropriate formatting and submission-readiness; checks for adherence to company style guide
•Assists medical writers with advanced word processing issues such as hyperlinking, bookmarking, references, and compilation of appendices;
•Understands how to use the company template to apply proper formatting and able to convey this knowledge to medical writers; Conducts QC reviews of hyperlinks, bookmarks, references, and compilation of appendices within assigned documents
•Ensures all relevant submission documents are accounted for within the Document Management System (as applicable)
•Develops Clinical Quality Control (CQC) SOPs and Working Instructions (WIs) and sets global quality standards which can be utilized throughout the Insmed organization.
•Troubleshoots and repairs documents while additionally conducting operational work within Medical Writing such as establishing publishing standards and processes with the Clinical Publishing Lead (CPL).
•This position has advanced word processing skills (eg, macros) and experience with Word, PDF, Adobe Acrobat, ISI Toolbox, and document management.

Qualifications: 

•Bachelor’s degree required; advanced degree preferred.
•Minimum of 5 years of quality control, document management and/or clinical publishing experience in the biotechnology or pharmaceutical industry also required.
•Progressive experience in medical writing is essential.
•Thorough knowledge of Good Publications Practices (GPP2) required.
•Must be familiar with style rules from the American Association Manual of Style.
•Understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems necessary,
•Must demonstrate a high-quality writing style in the English language.
•Must have excellent communication skills (verbal and written).
•Highly organized with a strong attention to detail, clarity, accuracy and conciseness.
•Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
•Demonstrated collaborative and cross-functional approach to delivering functional results is required.
•Must successfully exhibit Insmed’s five (5) core corporate competencies of: Excellence, Accountability, Driven, Collaborative and Solutions; along with any other position specific competencies.
•Individuals must demonstrate the ability to interact successfully in a dynamic and culturally diverse workplace.

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Other