CLINICAL SCIENCE MEDICAL WRITING COORDINATOR/ WHIPPANY NJ/ BYRJP00002532

  • Location
    Whippany, New Jersey
  • Job type
    Contract/Temporary
  • Category
    Medical & Science - Pharmaceutical Preclinical Development

Adecco is currently assisting a local client in their search to fill an exciting Clinical Medical Writer Coordinator role in Whippany, NJ!  Apply now if you meet the qualifications listed below!

 

 

DEPARTMENT/TEAM 
CS Medical Writing 

DESCRIPTION 
Most medical writing projects managed by the Global CS Medical Writing group involve the development of complex documents that are made up of multiple sections being sourced from multiple authors in multiple formats. The multiple sections are then compiled and published into the final document. 
The CS Medical Writing Coordinator reports to the Head of CS Medical Writing and is responsible for the tracking, quality control timely completion of the clinical documents related to global regulatory submissions across all therapeutic areas for these complex medical writing projects and for training new Medical Writing Coordinators. These projects include Clinical Study Reports (CSRs), abbreviated CSRs, and Regulatory Submission Documents (e.g. Module 2.7.1 and 2.7.2). 
In addition, the incumbent is responsible for maintaining all databases used by the Medical Writer to track and manage the overall medical writing process. 
 

POSITION DUTIES & RESPONSIBILITIES 

  • Uses project management skills to coordinate, track, review and ensure timely completion of high quality documents.
  • Provides to the medical writer (located either locally or remotely) assigned to a writing project, all source documentation from the electronic archive needed to author the document (e.g. statistical table sets, reference documents, subject data listings, etc.).
  • Manages CSR process starting from database closure up to final CSR registration for studies with an external medical writer.
  • Independently compiles complete drafts of report appendices for clinical phase 1 /2a studies.
  • Act as a central resource on all format- and style-related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintain departmental and project-specific style guides to reflect new agreements and changes due to SOPs, WPs, and regulatory guidelines. Provide updates to all medical writers (internal and external) regarding style, format, and content decisions.
  • Work with key interface partners to facilitate the completion of clinical study reports and their appendices. Ensure clinical documents adhere to global standards and are in accordance with electronic publishing Standards. Checks that study file components (e.g. Investigator CV’s, protocol and amendments, sample case report form) needed for the writing of CSRs are checked into the electronic archive (e.g. eDMS) on a timely basis (i.e. based on agreed upon timelines for a writing project) and meet all global standards and regulatory requirements for format (e.g. heading styles, language, accuracy).
  • Proofreads, reformats and edits document text, as required, to ensure that all report appendices meet all requirements for formatting (e.g. styles, fonts, etc.) prior to final QC, compilation and publishing. Reviews and performs QC checks of all documents and appendices to ensure consistency between and within documents.
  • Manages the review and approval of documents in the document management system using standard procedures. Transfers clinical study documents from the individual study files into the electronic archive used to compile the final medical documents.
  • Ensures that all team members have the required document management and review tool training required to review, approve and sign documents and trains them if necessary
  • Supports the training of new medical writing specialists and coordinators

 

REQUIREMENTS/PREFERENCES 

  • Bachelor’s degree or equivalent with at least 3-5 years of experience the pharmaceutical industry in total, including a minimum of 2 years in Medical Writing and demonstrated working knowledge of scientific principles OR have an Associate’s Degree with at least 5-7 years of experience in these areas AND the incumbent should have familiarity with clinical research, statistics, and regulatory guidances, standards and requirements pertaining to regulatory medical writing worldwide (e.g. ICH, FDA, EMEA)
  • Experience should include working with complex documents, preferably pharmaceutical research and submission documents (e.g. clinical study protocols, clinical study reports, other submission documents
  • The incumbent must have experience in electronic document management and electronic regulatory submissions, tools and standards (e.g. Documentum based systems, Adobe Acrobat, ISI-Toolbox)
  • The incumbent must be able to work on a wide variety of medical writing projects and support multiple scientific writers with minimal supervision. He/she must be highly organized and capable of setting up and maintaining the necessary procedures to ensure all projects are completed according to agreed timelines
  • The incumbent must demonstrate strong communication skills, both written and verbal required to articulate concepts and ideas
  • The incumbent must be a skilled user of word processing applications (e.g. Microsoft Word and Excel)

 

Role: Contract

Title: Clinical Medical Writer Coordinator

Location: Whippany, NJ

Pay: negotiable based on experience

Start: 5/14/18

Duration: 12 months

Shift: M-F 8:00am-5:00pm

 

 

How to Apply: Click on “Apply Now” to be considered for this position or any other opportunities with Adecco.

 

IMPORTANT: This position is being recruited for by Adecco’s National Recruitment Center, not your local Adecco Branch Office. To be considered for this position, you must use the “apply now” button to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position listed above. For other opportunities available at Adecco go to www.adeccousa.com.

 

If you have any questions surrounding the application process, please feel free to reach out to: Lisbeth Vences at lisbeth.vences@adeccona.com. You can also email your most current resume in word format to the email listed.

 

 

The Adecco Group is a global leader in HR services.  Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world.  We offer employment opportunities at any stage in your professional career.  Contact us today to discuss available contract and direct hire positions.  Adecco Group provides one of the most comprehensive benefits packages in the industry to contract workers to include Holiday, 401(k), Insurance Benefit Plans and Service/Anniversary Bonus opportunities.

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

 

 



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