Technical Writer

Job Responsibilities:

· Prepare and review controlled process documents to ensure submitted procedures are compliant and meet the requirements of R&D document control procedures.

· Support Process Owners in the development and streamlining of content, including processing mapping and RACI tables.

· Work with subject matter experts and key functional department personnel to ensure timely development and accurate content of required documentation. Recommend revisions or changes in scope, formatting, and content as identified.

· Perform Quality Control reviews on process document content and formatting.

· Maintain and coordinate activities related to the document creation using the EDMS including document initiation, workflow support, revision, and retirement.

Key Qualifications

Education

· B.A. or B.S. degree or equivalent required

Experience

· Minimum of five (5) years of experience writing controlled documentation in the biotechnology or pharmaceutical industry

· Direct experience in GXP-compliant quality systems is preferred

· Knowledgeable in FDA regulations

· Experienced in Microsoft office applications specifically Word, Excel and Visio

Skills

· Ability to maintain keen attention to detail with a high regard for quality, efficiency, and processes;

· Excellent communication skills including: technical writing, interpersonal and collaborative skills;

· Excellent organization skills with the ability to stay accountable to deliverables and milestones;

· Ability to thrive and multi-task in a steady-paced environment;

· Must have in-depth knowledge and understanding GXP regulations, and controlled

· document management principles;

· Must work effectively in a team environment and with individuals at all levels within an organization.

· Bachelor degree with 5 years of experience is ideal, will consider no bachelor in lieu of more experience

· GCP/GDP/GLP knowledge is needed

· Some background with EDMS is needed

· Experience about Process Map and writing SOPs are needed

· Candidate has to be from Biotech/Pharma industry, knowledge about FDA regulations is required

· Some document management experience will be a big plus

Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus. 

Thank you for your time and consideration. I look forward to hearing from you!

Kind Regards

Ruchi Kumari

Clinical Recruiter

Integrated Resources, Inc.

IT Life Sciences Allied Healthcare CRO

Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

(DIRECT BOARD) # 732-844-8716 (F) 732-549-5549

LinkedIn: https://www.linkedin.com/in/ruchi-kumari

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