Medical Writer job Woodcliff Lake New Jersey
Medical Writer job Woodcliff Lake New Jersey
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Medical Writer Job



Employer Name: SpiderID: 8111406
Location: Woodcliff Lake, New Jersey Date Posted: 10/30/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH28260

Job Description:

Job Summary



  • Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents within his human health care pharmaceutical company.

  • This is a FULL time 40 hour work week. Would prefer full time onsite 5 days a week, however we will accept someone to work remotely but must work 3 days minimum onsite.


Responsibilities



  • Preparation of regulatory documents on behalf of the Company in accordance with the ICH guidelines, international regulations, Company standards and processes, and the Company's Writing Style Guide as applicable.

  • Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator brochures, and submission documents. Participate in project team meetings to provide input regarding deliverables, timelines, and processes.

  • Responsible for managing the document review process. Route documents for approval.

  • The medical writer should be familiar with ICH guidelines and the current AMA Style Manual.

  • The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines.


Qualifications
Education



  • Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred.


Experience



  • 5+ years medical writing experience within a major pharmaceutical company.

  • Prior experience in oncology is a plus.

  • The most important requirement is the ability to independently write regulatory documents in collaboration with the various members of study team.


Skills



  • Must be team orientated

  • Excellent regulatory writing skills, meticulous attention to detail, proficiency using an electronic document management system and standard style guide, and strong analytical ability to interpret clinical data.




Please submit your resume for consideration. Once submitted, feel free to contact Sanka at 646-856-8903 for additional information.

Approx. Duration: 12 months

About Hired By Matrix

Hired by Matrix, Inc. founded in 1986, is a certified Woman-Owned Business Enterprise (WBE) dedicated to providing the highest quality of job opportunities to our candidates and staffing services to our clients. We are a full service staffing firm with experience recruiting and delivering for IT, Accounting & Finance, Administrative & Clerical, Clinical & Scientific, and Marketing disciplines. Our long history in the staffing industry and dedication to excellence are the key differentiators that have fueled our success for over 30 years.

Hired by Matrix offers our contract professionals competitive salaries, benefits after 60 days and a 401k option after one year.
Equal Opportunity Employer
WBENC Certified
WOSB Certified
*CEO Sharon Olzerowicz serves on the WBENC Board and is a long-standing member of the Forum Governing Group.

We work hard to match our candidates with the right career opportunities. Let us find you a #MatrixMatch so you can reach your career goals!

Connect with us on LinkedIn and see how we can impact your career!

Hired by Matrix Career Center: https://www.hiredbymatrix.com/find-work/open-positions/



Job Criteria:
Start Date:
Position Type: Contractor
Years of Experience Required:
Education Required:
Overnight Travel:
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Contact Information:
Contact Name: Hired by Matrix, Inc. Company Type:
Company: Hired by Matrix, Inc.
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