Medical Writer

Company Description

A Few Words About Us
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

With todays growing demand for talented and well qualified professionals, its more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth.

IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ.

We have been honored by the following:

Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009
Top 500 Privately-Held Business in the US
Top 500 Diversity Owned Business in the US
Top 100 Subcontinent Asian American Business in the US
We have also been listed to the Inc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010 and honored as an Emerging Business of the Year finalist by NJ BIZ in 2009.

Job Description

Job Description:

In this role, incumbent will be expected to provide Medical Writing leadership for clinical development, registrational, and LCM programs. Serves as lead Medical Writer for key programs. Coordinates medical writing support for programs with internal and contract writers.

Additionally, must posess the ability to guide and assists medical writers in the writing of documents that are components of clinical/ regulatory approval applications for new biologics or NME applications. Documents include: Sections of clinical trial applications, Annual Reports, and BLA/NDAs, Protocols and Protocol Amendments, Model Informed Consents, Model Privacy Consents, Investigator Brochures, Clinical Study Reports, and Expert Reports and other documents as appropriate. 

Additional skills:
must be a strong technical leader, manage with excellent scientific, strategic and customer focused leadership.
Partner with Clinical Operations and R&D team members to ensure completion of high quality, timely, clinical documentation.

Expected Qualification: Masters or PhD in biology or related discipline. Equivalent combination of education and experience considered. 7+ years of related experience in biotech or pharmaceutical environment. Must have strong scientific and operational background. At least 3 years of experience managing staff.

Qualifications

Additional Information