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Job Details

Sr. Medical Writer

Company name
Integrated Resources, Inc.

Location
Lexington, MA

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Sr. Medical Writer

Integrated Resources, Inc.

Lexington

MA

Job #668217016

Title: Sr. Medical Writer Location: Lexington, MA Duration: 08 months Description: The Lead Medical Writer (MW) is responsible for medical writing activities for a program (eg, a compound with one indication or single indication within a compound or several compounds if scope is small). With some oversight, provides strategic direction to cross-functional project team to ensure that clinical documents (eg, investigators? brochures, study protocol and amendments, study reports, marketing authorization submission documents) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements. Lead development of quality deliverables (development, review, approval) that are scientifically rigorous, logically organized, and accurate data presentation and interpretation. Activities (performed with some oversight) include, but are not limited to, writing, development of timelines, project management of the MW deliverables, participation on project team. May mentor less experienced writers. Generally leads or participates on departmental or cross-functional initiatives designed to establish best practices and efficient cross-functional collaboration. Job Function and Description: Leading the MW activities for assigned project(s) including writing key deliverables. Leading or participating on non-project related initiatives Key Skills, Abilities, and Competencies: Ability to understand and interpret clinical and scientific data with minimal oversight; Ability to define data presentation to meet key messages developed by the clinical team. Ability, with some oversight, to lead the development, review, and approval of all clinical document types (ie, those typically developed by MW) Basic project management skills including understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups Ability to manage work timelines within assigned program(s). Strong written presentation skills and ability to present information to others Effective oral presentation skills (ie, ability to effectively lead a meeting and present issues) Ability to interact effectively with team members/leaders Ability to assess issues and develop potential solutions Working knowledge of current global regulatory requirements/guidelines applicable to clinical research (eg, GCP) Working knowledge of the regulatory guidance regarding content for various document types including, but not limited to, ICH E3 (CSRs), ICH E6 (IBs), ICH M4, ICH E2E, EMA guidance on RMPs). Strong knowledge of MS Word (required), Excel (preferred), Project (preferred), Powerpoint (preferred), and Outlook. Working knowledge using an electronic document management system; Ability to use document templates; ability to work with multiple document template styles and types. Education: Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor?s degree required. 5-7 years’ experience in clinical/pharmaceutical development with directly related medical writing experience. Global regulatory submission experience preferred.

Updated 05/17/2018

Company info

Integrated Resources, Inc.
Website : http://www.irionline.com/

Company Profile
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 today’s growing demand for talented and well qualified professionals, it’s 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.

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