Nonclinical Regulatory Document and Scientific Writer Job at ASK Consulting, Summit, NJ

MVRRK1M0TmxzS0E4UlJScHBVcE85R3Y5
  • ASK Consulting
  • Summit, NJ

Job Description

"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.

Job Tags

Flexible hours,

Similar Jobs

Stealth Recruiting Services

Emergency Medicine Physician Job at Stealth Recruiting Services

325000k to 380000k Job Description Emergency Medicine Physician - Direct Hire Full-time Competitive Salary Excellent Benefits Package Relocation Assistance Bonus Eligible Interview Travel Reimbursed Willingness to Travel - Occasionally Location... 

Creating Brighter Futures Brad and Sue Cann

Business Success Coach Job at Creating Brighter Futures Brad and Sue Cann

 ...fits your life Rewarding independence: Be your own boss and reap the benefits of your hard work. Join us as a Business Success Coach and establish a flourishing remote business in a booming industry, even amidst challenging times. About Us Along with our... 

University of Pennsylvania

Clinical Research Assistant A/B Job at University of Pennsylvania

 ...Clinical Research Assistant A/B University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top... 

Syndicatebleu

Digital Media Manager Job at Syndicatebleu

 ...A non-profit organization is seeking a talented and innovative Digital Communications Manager to lead and enhance the organization's social and digital media efforts. This role is instrumental in advancing the organization's mission by developing, editing, and publishing... 

Larsen & Toubro

Plant Modelling Simulation Engineer Job at Larsen & Toubro

 ...Job Description & Skill Requirement: Mandatory skill Overall Exp: Min 6 years in Automotive Plant Modelling Exp :Min 4 years plant modelling (Physics based plant model development & not testing of plant models) Min 3 years of hands on exp in MATLAB-Simulink...