Skip navigation
Unable to save this job. Please try again later.

{msg}

Email this Job to Yourself or a Friend

To begin the application process, please enter your email address.

Company Contact Info

  • Bernards, NJ 07920

Already have an account?

Sign in to apply with your saved resumes.

New to CareerBuilder?

Don't have an account? Continue as a guest!

Sorry, we cannot save or unsave this job right now.

Report this Job

Trust and Site Security Team.

Don't miss out on new jobs!

Get the latest Assoc Dir Medical Writing jobs in Bernards, NJ delivered directly to your inbox. You can unsubscribe at any time.

Saving Your Job Alert

Job Alert Saved!

Could not save Job Alert!

You have too many Job Alerts!

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.

Sign Up

or   Sign In Here
Password Must Contain
• 
8 to 15 characters
• 
1 uppercase letter
• 
1 number or symbol
• 
1 lowercase letter
Cancel
Create an Account with CareerBuilder to save jobs & unlock these great features
See similar job titles and skills to help you make your next move
Upload a resume and become visible to Hiring Managers and Employers
Compare Salary Information to see where you stand amongst your peers
Easily Quick Apply to jobs with just one click!

Email Send Failed!

Assoc Dir Medical Writing

Daiichi Sankyo, Inc. • Bernards, NJ

Posted 26 days ago

Job Snapshot

Full-Time
Other Great Industries
Other

Job Competition

1

Applicant

How Do You Compare to the Competition?

Get facts about other applicants with a CareerBuilder Account

Job Description

About Daiichi Sankyo Cancer Enterprise
The vision of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by three pillars including our investigational Antibody Drug Conjugate Franchise, Acute Myeloid Leukemia Franchise and Breakthrough Science Franchise, we aim to deliver seven distinct new molecular entities over eight years during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno-oncology and small molecules in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA.

Job Summary:
The primary responsibilities of this position are to establish strategies for document authoring, contribute strategically and scientifically at the project and/or study team level, manage CROs and external writers with regard to document quality, and develop medical writing timelines, processes, and working standards. The position can independently serve as primary author of complex clinical documents (e.g., pivotal Phase 3 protocols and reports) and be a lead writer for NDA/MAA submission documents. This position has advanced knowledge of NDA/MAA submissions, knowledge of document management systems, knowledge relevant therapeutic areas, and knowledge of other aspects of drug development (e.g., nonclinical, pharmacokinetics, biostatistics).

Responsibilities:
  • Establishes strategy for document authoring; Determines resource needs, proactively identifies issues and solutions, and sets timelines and processes
  • Writes critical, complex clinical documents (e.g., pivotal Phase 3 protocols and reports, NDA/MAA submission documents) with minimal input from functional area experts; Ensures key messages are clear and consistent within and across documents; Able to independently search scientific literature to place study results in context with other relevant data
  • Contributes strategically and scientifically at the project and/or study team level; Contributes to formation of key messages in consultation with functional area experts (e.g. Recommending data outputs for collection of specific data, proposing document strategy for filings or responding to health authority requests); Advises project and study teams regarding regulatory requirements and ICH guidance for clinical documents
  • Manages CROs and external writers with regard to document quality; Provides guidance to CROs and external writers on company standards and style and industry best practices for medical writing
  • Develops medical writing timelines, processes, and working standards; Ensures company SOPs, templates, style guides, etc, are aligned with industry best practices
  • Manages other MWs, assess performance and perform mid and end of year appraisals
Qualifications:
  • Minimum 5-7 years of experience with a Master's of Science degree or PhD or
  • Minimum 7+ years of experience with a Bachelor's degree
  • Regulatory Medical writing experience required
  • Submission document experience required
Job ID: 9449BR
Help us improve CareerBuilder by providing feedback about this job: Report this Job.
CAREERBUILDER TIP
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.
Don't miss out on new jobs like this
Get the latest jobs delivered to your inbox. Unsubscribe at any time.

Saving Your Job Alert

Job Alert Created

Well, this is embarrassing. We are having trouble saving your search. You can try again or come back at a later time.

Maximum Email Alerts

This email address has reached the maximum of 5 email alerts. To create a new alert, you will need to log into your email and unsubscribe from at least one.