Direct Hire - Senior Manager, Medical Writing - NEUROSCIENCE job Woodcliff Lake
Direct Hire - Senior Manager, Medical Writing - NEUROSCIENCE job Woodcliff Lake
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Direct Hire - Senior Manager, Medical Writing - NEUROSCIENCE Job



Employer Name: SpiderID: 8111160
Location: Woodcliff Lake, New Jersey Date Posted: 10/30/2018
Wage: Negotiable Category: Medical/Health
Job Code: BBBH28256

Job Description:

Job Summary



  • Our Client, a human health care pharmaceutical company, is seeking a Sr Mgre, Medical Writing - Neuroscience possessing 6 years NS experience.

  • The Senior. Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Neuroscience Programs.

  • As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management, with support from management as needed.

  • The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers

  • Remote 1 day week.


Responsibilities Include but are not limited to:



  • Independently preparing PCS, protocols, and protocol amendments often acting as the compound lead

  • Independently preparing all sections of the CSRs, including narratives, working across functional areas to obtain all applicable source material

  • Routinely engaging clinical research and biostatistics to gain comprehensive understanding of study design, objectives and results

  • Providing guidance to other medical writers applying industry and medical writing best practices
    With minimal supervision, preparing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reports

  • Contributing to the writing of marketing application submission documents

  • Managing processes for obtaining feedback for improvements for the document standards and structure

  • Providing mgmt. with appropriate information to ensure procurement of adequate and timely resources to complete medical writing deliverables

  • At the Director's discretion, may provide work direction to contractors/consultants
    Contributing to process improvement within and across functional areas

  • Influencing medical writing strategies and processes within and across functional areas

  • Working with teams to develop project specific metrics compliant with standard project metrics
    Monitoring and evaluating project metrics, escalating issues as needed


Qualifications
Education



  • Bachelor's Degree required; an advanced degree is preferred.


Experience



  • Minimum of 5 years' medical writing experience in CNS, with specific experience with compounds targeted for epilepsy preferred

  • Must have participated in a major marketing application submission

  • Experienced in the use of a document management system


Skills



  • Strong critical thinking and problem solving skills

  • Self-motivated with the ability to influence others

  • Ability to multitask

  • Result driven with the ability to demonstrate time management and project planning

  • Able to work on site

  • Advanced working knowledge of MS project and MS Word




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

Approx. Duration: Perm

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:
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Position Type: Full-Time Permanent
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