Senior Consultant

Hyderabad, AP, IN

Senior Consultant - (CREQ103678)


Position Summary
Technical Writer will support the content development and revisions of various procedural and validation documentation aligning with regulatory requirments They will be required to organize content into a document that can be easily understood
The jobholder will have the opportunity to work in key and strategic projects in a very dynamic environment This position offers excellent opportunities of personal development depending on candidate motivation and competencies
Essential Duties & Responsibilities Detailed Description
Serve as the technical writer for developing written documents pertaining to Plans and Summary Reports Risk Assessments Design ConfigurationSpecification User and Functional Requirements Trace Matrix etc meeting regulatory standards
Work closely with subject matter experts SMEs and senior leaders to collect interpret and synthesize information needed to develop each written document
Perform quality reviews to ensure each document is accurate consistent with FDA laws regulations and policies includes all important concepts meets the writing style requirements of the agency follows the appropriate template and are written at an appropriate comprehension level for the intended audience
Produce working and final drafts of each written document for review by SMEs and senior leaders within specified timeframes
Knowledge Skills And Abilities
Demonstrate strong knowledge of current 21 CFR Part 11 GxP requirements and Quality Systems
Evaluate develop and revise Digital Process and Validation SOPs Forms and Documentation to meet business and regulatory requirements
Demonstrate ability to explain complex concepts with clarity and simplicity
Demonstrate ability to perform detailoriented work with a high degree of accuracy
Demonstrate strong verbal written and interpersonal communication skills
Familiarity with organizational change management concepts
Experience with SDLC methodologies in a cGxP regulated environment
Selfdirected with effective analytical and problemsolving skills
Capable of operating within a fastmoving business environment
Excellent documentation and communications skills
Strong working knowledge of Microsoft Office
Strong interpersonal skills with ability to work collaboratively within a team of stakeholders
Qualifications & Experience
Relevant Bachelors or Masters degree is science or engineering
Excellent verbal and written communication in English
Proven technicalprofessional writing experience
Certification in US HealthCare or LifeSciences system is preferred
Minimum 5 years of professional experience as a Technical Writer preferably in the LifeSciences domain
Extensive experience in FDA GxP 21 CFR Part 11 and other regulations
Physical & Mental Requirements
Maintains positive attitude towards customers in conflicting situations
Demonstrates excellent interpersonal skills dedicated to success of the team as a whole
Has highly developed analysis and problem solving skills
Demonstrates outstanding written and verbal communication skills including the ability to write and speak persuasively tactfully and diplomatically in English
Able to remain selfmotivated keep positive attitude and adapt rapidly to continuous change
Shows dedication and persistence in acquiring new responsibilities and skills
Proficient in handling a high volume of work with conflicting demands

Primary Location

: IN-AP-Hyderabad


: Full Time

Employee Status

: Individual Contributor

Job Type

: Experienced


: No

Job Posting

: 13/10/2021, 1:00:52 PM
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