Medical Writer II

ID# DCNJ27105

dinaliC is an international consulting firm specialized in projects for numerous industries. We are dedicated to provide contract and permanent opportunities for skilled professionals in their area or areas of expertise

JOB OVERVIEW 

The applicant will write Criticality Analysis documents for Pharmaceutical Products. The applicant should have experience writing pharmaceutical manufacturing batch records, process validation protocols and reports, process development and scale-up reports, SOPs pertaining to manufacturing, process flow diagrams, FMEAs. Requires an understanding of manufacturing processes for tablets, capsules, liquid, cream, and/or parenteral manufacture. A minimum of Five (5) years experience is required. The applicant should be proficient in Microsoft Word, Excel, Visio, Microsoft Project and have experience with documentation systems. 

The incumbent will work with technical, manufacturing and quality groups to develop a Criticality Analysis document for pharmaceutical products. Job Responsibilities include. 

  • Assist teams by pre-populating the document based on provided process flow diagrams, manufacturing batch records and other supporting documents. (the incumbent should have the ability to search these documents, understand the process and extract required information) 
  • Ensure proper formatting, proof read, and route for approval in documentation system. 
  • Maintain and update project status in Microsoft Project 

Key Decisions: 

  • Participates in decisions and provides input regarding the adequacy, accuracy, interpretation, and clarity of technical information/reports prepared by plant functional groups to support submission-related activities 
  • Consults with appropriate groups (as required) regarding the acceptability of  documentation 

Key Competencies: 

  • Project Management 
  • Organization and Time Management 
  • Communication (Verbal, Written, and Interpersonal) 

Education/Experience Requirements: 

  • Bachelor's degree in Chemistry, Pharmacy or a related science field plus 4-6 years of relevant experience industrial experience in the healthcare industry 
  • OR MS/PhD/Pharm.D. plus 3-4 years of pharmaceutical industrial experience. 
  • Minimum of 1-2 years of technical writing experience for manufacturing related activities is mandatory 
  • Experience working in the Pharmaceutical manufacturing industry (preferably in Technical Services, Operations, manufacturing plant or Research & Development or QA, knowledge of pharmaceutical development processes, cGMPs and regulatory requirements are required 
  • Excellent English, writing and oral presentation skills mandatory 
  • Prior experience with Pharmaceutical Industry mandatory 
  • Prior experience managing projects is preferred 

Job Description: 

Write technical materials, such as SOP's, appendices, 

Duties and Responsibilities: 

  • Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology. 
  • Maintain records and files of work and revisions. 
  • Edit, standardize, or make changes to material prepared by other writers or establishment personnel. 
  • 2+ years experience as a Technical Writer 
  • 2+ years primary role writing user documentation for a variety of products, prepared as part of an integrated team. 
  • Proofing/preparation of documentation,

 

Position Details:

Pharmaceutical

Scientific

Start Date: 
9-20-2013
End Date: 
9-19-2014

RARITAN, NJ

Full Time

37.5

DCNJ27105

No

No