Telangana Author Jobs – 134 Open Jobs Today

Global Regulatory Writing – Senior Manager
Amgen —Hyderabad, Telangana
- Doctoral degree
- Word processing
- Writing skills
Biostatistics Sr Assoc (Study Statistician)
Amgen —Hyderabad, Telangana
- Doctoral degree
- English
- Master's degree
6d
Senior Associate Endpoint Security Engineer
Amgen —Hyderabad, Telangana
- Computer science
- Windows
- Master's degree
8d
OpEx Manager
Reckitt —Hyderabad, Telangana
- Project management
- Bachelor's degree
- Mentoring
- Health insurance
13d
Editor/Writer, Tax Current Awareness
Thomson Reuters —Hyderabad, Telangana
- Full-time
- Hybrid work
- Microsoft Excel
- Writing skills
- Research
- Work from home
Senior Revenue Cycle Specialist - Work From Home
ClinicMind —Hyderabad, Telangana
- Remote
- Microsoft Excel
- English
- Finance
- Work from home
Quick apply
EDITORS/PROOFREADERS
BSP Books —Hyderabad, Telangana
- Microsoft Word
- English
- Microsoft Office
.NET Engineer with AI Assisted Development Tools
Rinf.tech —Hyderabad, Telangana
- Full-time
- AI
Research Scientist - Generative AI & Foundation Models
YAL —Kothaguda, Telangana
- Doctoral degree
- Computer Science
- Research
Quick apply
Applied Scientist II, Sheriff Team- Payroll tech
ADCI HYD 13 SEZ —Hyderabad, Telangana
- Full-time
- Doctoral degree
- Customer service
- Research
Associate Specialist, Tester
MSD —Hyderabad, Telangana
- Full-time
- Azure
- Computer Science
- Java
14h
Manager, C&Q Document Preparation (Manufacturing Support)
Amgen —Hyderabad, Telangana
- Master's degree
- Bachelor's degree
- Organisational skills
Specialist IS Engineer - System Implementation & Development
Amgen —Hyderabad, Telangana
- Azure
- Computer Science
- Public speaking
Senior Model Validation Analyst II(Python/R)
Verisk —Hyderabad, Telangana
- Full-time
- SQL
- AWS
- Bachelor's degree
Principal Threat Research Lead
Microsoft —Hyderabad, Telangana
- Full-time
- Azure
- Research
- Master's degree
13d
Executive - DQA
Piramal Pharma Limited —Digwal, Telangana
- Full-time
- Master's degree
- APIs
1d
Product Manager, Manufacturing Execution & Batch Lifecycle
ValGenesis —Hyderabad, Telangana
- Full-time
- Computer science
- Doctoral degree
- B.Sc
Quick apply
Technical Solutions Consultant, PDM-PLM
Google —Hyderabad, Telangana
- Full-time
- Computer Science
- Engineering
- System design
Principal Product Manager Technical, Associate Experience
ADCI HYD 13 SEZ —Hyderabad, Telangana
- Full-time
- Customer service
- Bachelor's degree
6d
Specialist Stability
Amgen —Hyderabad, Telangana
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel

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Global Regulatory Writing – Senior Manager

Amgen -
Hyderabad, Telangana

Apply Now

Job details

Freelance

Qualifications

Doctoral degree
Word processing
Writing skills
Microsoft Office
Master's degree
12th Pass
Project management
Bachelor's degree
Technical writing
Document management systems
Leadership
Communication skills
Editing

Full job description

India - Hyderabad

JOB ID: R-242349 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Jun. 16, 2026 CATEGORY: Regulatory

Group Purpose

To prepare scientific and regulatory submission documents that comply with global regulatory standards.

Job Summary

To author and gain approval of scientific and regulatory submission documents that comply with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. This role serves as functional area lead on product teams, leads writing activities for complex product submissions providing functional area expertise, trains and mentors more junior writers, and leads departmental activities.

Key Activities

Independently:

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric Investigation Plans, and other regulatory documents;
Conduct the formal review and approval of authored documents, following applicable standard operating procedures;
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications;
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
oversee the work of contract and freelance writers train, mentor, or supervise more junior medical writers, as assigned
lead departmental and cross-departmental initiatives, as appropriate
Generate document timeline and keep abreast of relevant professional information and technology

Knowledge and Skills

Required Knowledge and Skills:

Ability to independently analyze scientific data and interpret its significance in practical applications;
Excellent written/oral communication skills and attention to detail;
Highly skilled in word processing and other Microsoft Office programs
Expertise in scientific/technical writing and editing, and of overall clinical development process for new compounds;
Must demonstrate strong leadership skills in a team environment which requires negotiation, persuasion, collaboration, and analytical judgment;
Ability to understand, follow, and develop complex standard operating procedures (SOP’s), guidance documents, and work instructions;
Excellent time and project management skills
Self-starter with a drive and perseverance to achieve results and motivate others

Preferred Knowledge and Skills:

Deep understanding and application of principles, concepts, theories and standards of scientific/technical field.
Advanced knowledge of document management systems.
Expert knowledge and understanding of International Council on Harmonisation (ICH) and Good Clinical Practice (GCP) guidance's and requirements relevant to regulatory submissions.

Education & Experience (Basic)

Doctorate degree and 2 years of directly related experience
OR
Master’s degree and 6 years of directly related experience
OR
Bachelor’s degree and 8 years of directly related experience
OR
Associate’s degree and 10 years of directly related experience
OR
High school diploma / GED and 12 years of directly related experience

Education & Experience (Preferred)

Industry experience

12-17 years experience in writing clinical and regulatory documents for all phases of regulatory submissions (INDs to NDAs)

Apply Now

Refine Your Search

author jobs in telangana

Global Regulatory Writing – Senior Manager

Biostatistics Sr Assoc (Study Statistician)

Senior Associate Endpoint Security Engineer

OpEx Manager

Editor/Writer, Tax Current Awareness

Senior Revenue Cycle Specialist - Work From Home

EDITORS/PROOFREADERS

.NET Engineer with AI Assisted Development Tools

Research Scientist - Generative AI & Foundation Models

Applied Scientist II, Sheriff Team- Payroll tech

Associate Specialist, Tester

Manager, C&Q Document Preparation (Manufacturing Support)

Specialist IS Engineer - System Implementation & Development

Senior Model Validation Analyst II(Python/R)

Principal Threat Research Lead

Executive - DQA

Product Manager, Manufacturing Execution & Batch Lifecycle

Technical Solutions Consultant, PDM-PLM

Principal Product Manager Technical, Associate Experience

Specialist Stability

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