Demo

Nonclinical Regulatory Document and Scientific Writer

ASK Consulting
Summit, NJ Full Time
POSTED ON 2/5/2025
AVAILABLE BEFORE 5/3/2025

All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable to provide sponsorship at this moment".

Job Title : Nonclinical Regulatory Document and Scientific Writer

Location : Summit, NJ

Duration : 12 months

Pay rate : $57.78 / hr on W2

Job Description : 50% Onsite

  • Strong background in nonclinical Pharmacokinetics and experience with Global Health Authority interactions.
  • Experience reviewing regulatory documents, DMPK and BA reports, and non-GLP / GLP data and notebooks.
  • Pharmaceutical / biotech industry experience of >

5 years.

Responsibilities include :

  • Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents. Including, but not limited to, INDs, CTAs, NDAs, BLAs, IBs, Pediatric Investigative Plans and regular updates of such documents. Regulatory submissions will span across all therapeutic areas (cancer, immunology, neurology etc.) and all modalities, including small molecule, large molecule, and cell therapies. Candidates will support multiple drug development programs. Drug development programs are global, so candidates will work on programs intended for US, EU, Japan and other world markets.
  • Assist with quality review of DMPK reports that are generated by DMPK scientists by fully reviewing the raw data outputs / electronic notebooks and ensuring validity and quality of reported data in the reports, in addition to reviewing DMPK regulatory documents, editing of nonclinical study reports for regulatory acceptance and adherence to company templates, SOPs, DMPK / BA methods, work practices and FDA GLPs, as applicable. Ability to re-prioritize QC workloads quickly when needed, while meeting all necessary timelines.
  • Assist in addressing Health Authority questions pertaining to DMPK and BA with the SMEs and Regulatory representatives.
  • Determine and manage document timelines through authoring, review cycles and on time completion.
  • Attend department group meetings for tracking and management of upcoming needs for nonclinical documentation.
  • Understand the impact of DMPK / BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.
  • Other duties related to the above within client, as assigned.
  • Skills / Knowledge Required :

  • At minimum, a Bachelor's degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs.
  • Regulatory drug development experience of >
  • 5 years.

  • Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
  • A strong knowledge of DMPK / BA methods, data interpretation and terminology is necessary.
  • Strong analytical and problem-solving skills, with the ability to manage multiple projects and teams simultaneously.
  • Exceptional project management and organizational skills to be flexible and adaptable to changing project priorities and work assignments.
  • Strong interpersonal and communication skills, be a team player, able to self-advocate and willing to work in an environment where individual initiative and accountability are required.
  • Careful attention to detail.
  • Excellent scientific writing, strong QC review skills, and verbal communication skills required.
  • Experience in Watson LIMS software and electronic laboratory notebooks a plus.
  • Robust PC experience :

  • Training on in-house document repository system will be provided.
  • Microsoft Office Suite experience required including Microsoft Word, Excel, and Outlook.
  • About ASK : ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

    ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

    Salary : $58

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a Nonclinical Regulatory Document and Scientific Writer?

    Sign up to receive alerts about other jobs on the Nonclinical Regulatory Document and Scientific Writer career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $158,871 - $208,222
    Income Estimation: 
    $207,108 - $274,494
    Income Estimation: 
    $140,918 - $196,956
    Income Estimation: 
    $188,947 - $264,846
    Income Estimation: 
    $176,359 - $246,541
    Income Estimation: 
    $158,728 - $233,218
    Income Estimation: 
    $63,371 - $83,018
    Income Estimation: 
    $77,272 - $101,684
    Income Estimation: 
    $78,084 - $104,270
    Income Estimation: 
    $75,043 - $100,052
    Income Estimation: 
    $78,084 - $104,270
    Income Estimation: 
    $95,800 - $126,196
    Income Estimation: 
    $97,803 - $128,184
    Income Estimation: 
    $95,508 - $129,349
    Income Estimation: 
    $97,803 - $128,184
    Income Estimation: 
    $122,529 - $166,597
    Income Estimation: 
    $123,229 - $164,502
    Income Estimation: 
    $123,155 - $167,827
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at ASK Consulting

    ASK Consulting
    Hired Organization Address Remote, OR Temporary
    Job Description Job Description All candidates must be directly contracted by ASK Consulting on their payroll and cannot...
    ASK Consulting
    Hired Organization Address Boston, MA Full Time
    Job Details Job Description Job Description "All candidates must be directly contracted by ASK Consulting on their payro...
    ASK Consulting
    Hired Organization Address Kent, WA Full Time
    All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable...
    ASK Consulting
    Hired Organization Address St. Louis, MO Full Time
    All candidates must be directly contracted by ASK Consulting on their payroll and cannot be subcontracted. We are unable...

    Not the job you're looking for? Here are some other Nonclinical Regulatory Document and Scientific Writer jobs in the Summit, NJ area that may be a better fit.

    Regulatory & Medical Affairs - Document Publisher

    Futran Tech Solutions Pvt. Ltd., Jersey, NJ

    Senior Appellate Counsel, Enforcement

    Financial Industry Regulatory Authority, Jersey, NJ

    AI Assistant is available now!

    Feel free to start your new journey!