Sr. Technical Writer Position Available In Morris, New Jersey

Job Details Scientific
Sr. Technical Writer Whippany, NJ Job Description
Job ID#: 114036

Category:

Scientific Job Type:

Temporary Branch:

Parsippany Salary:

$ 45.00

• $ 50.

00

Phone:

(973) 299-9920 POSITION SUMMARY

• Write technical documents, such as SOPs, analytical protocols, reports, specifications, test methods, risk assessments, appendices, operating and maintenance instructions and formal investigations.
• Support stability program, analytical data review and any other QC/AD functions when and where required.
• Train junior technical writers to produce high-quality documentation.

ESSENTIAL FUNCTIONS

• Maintain records and files of work and revisions.
• Prepare and write analytical protocols, reports, and technical documents.
• Prepare specifications, test methods and test reports for raw materials and drug products.
• Perform all routine activities for stability program, including stability registration, stability protocol/report preparation, stability chambers monitoring, stability sample management etc.
• Edit, standardize, or make changes to material prepared by other writers or establishment personnel.
• Confer with customer representatives, vendors, plant executives to establish technical documents and to determine subject material to be developed for product filing.
• Review published materials and recommended revisions or changes in scope, format and content.
• Observe developmental and experimental activities to determine operating procedure and detail.
• Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology.
• Analyze developments in specific fields to determine the need for revisions in previously published materials and development of new material.
• Other duties as assigned Job Requirements

REQUIRED QUALIFICATIONS

• Scientific background, preferably in Chemistry. Proven working experience in technical writing of analytical documentation
• Familiarity with aseptic processing and sterile manufacturing environments. Experience with sterile products related technical guidelines and documentation.
• Excellent written skills in English.
• Strong working knowledge of Microsoft Office.
• Communication, Written
• Ability to communicate in writing clearly and concisely.
• Sound technical writing skills, verification skills and a strong understanding of scientific concepts.
• Contribute to the preparation of regulatory filing documents and other technical documents through authoring and verification of the documents.
• Knowledge of ICH, FDA, and EMA regulations.

Strong documentation skills, strong

GMP, GLP.

• Accuracy
• Ability to perform work accurately and thoroughly.
• Adaptability
• Ability to adapt to change in the workplace.
• Detail Oriented
• Ability to pay attention to the minute details of a project or task.
• May have publications, or experience in presentation of findings to scientific organizations.
• Organized
• Possessing the trait of being organized or following a systematic method of performing a task.

EDUCATION

• A minimum of a bachelor”s degree in chemistry, pharmaceutical science or a related science field
• A master”s degree in chemistry, pharmaceutical science or a related science field (preferred)

EXPERIENCE

• Minimum 10 Years working in QC/Analytical Development in pharmaceutical environment

Salary Range:

$45.00

• $50.

00 /hr