Hyderabad Telangana Clinical trials project management Jobs – 120 Open Jobs Today

Senior Regulatory Medical Writer
Jeevan —Hyderabad, Telangana
- Microsoft Powerpoint
- Microsoft Word
- Medicine
Manager, CSAR – Custom function Programming
Amgen —Hyderabad, Telangana
- Computer Science
- Project management
- Bachelor's degree
Biostatistical Programming Senior Associate
Amgen —Hyderabad, Telangana
- B.Sc
- Master's degree
- Bachelor's degree
Senior Director, Integration and Digital Data Flows
Amgen —Hyderabad, Telangana
- Master's degree
- Bachelor's degree
- In-person
12d
Principal Biostatistician (VAX)
Sanofi —Hyderabad, Telangana
- Doctoral degree
- English
- Research
Biostatistical Programming Mgr
Amgen —Hyderabad, Telangana
- B.Sc
- English
- Master's degree
Customer Support Engineer
MasterControl —Hyderabad, Telangana
- Online application
- Remote
- Software troubleshooting
- English
- Java
IT Delivery Lead - Technology IT
Signant Health —Ranga Reddy District, Telangana
- Full-time
- PMP
- Agile
- AI
7d
Senior Principal Clinical Programmer (Medidata RAVE)
Syneos - Clinical and Corporate - Prod —Hyderabad, Telangana
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Manager, Commercial AI Product Owner
Bristol-Myers Squibb —Hyderabad, Telangana
- Email
- Hybrid work
- Doctoral degree
- B.Sc
- HIPAA
Medical Monitor
AXIS Clinicals —Miyapur, Hyderabad, Telangana
- Full-time
- Medicine
- Master's degree
- Bachelor's degree
Senior Workforce Data Analyst
Syneos - Clinical and Corporate - Prod —Hyderabad, Telangana
- Full-time
- Microsoft Excel
- SQL
- Analysis skills
Specialist IS Engineer - System Implementation & Development
Amgen —Hyderabad, Telangana
- Azure
- Computer Science
- Public speaking
Global HEOR Evidence Synthesis Manager
Amgen —Hyderabad, Telangana
- Full-time
- Microsoft Excel
- Doctoral degree
- English
Sr. Manager, Data Governance Lead – Domain Specific
Amgen —Hyderabad, Telangana
- Management
- Public speaking
- Research
Senior Data Engineer
Statistics & Data Corporation (SDC) —Hyderabad, Telangana
- Full-time
- Hybrid work
- System design
- Research
- SQL
- Paid time off
- Flexible schedule
Quick apply
Business Controls Function (BCF) Automation Manager
Bristol-Myers Squibb —Hyderabad, Telangana
- Email
- Hybrid work
- English
- Master's degree
- SQL
12d
Manager, Logistics
Amgen —Hyderabad, Telangana
- Microsoft Access
- Master's degree
- 12th Pass
Clinical Translation Executive
FORWARD LIFE PVT.LTD —Ameerpet, Hyderabad, Telangana
- ₹10,000 - ₹13,000 a month
- Full-time
- Doctoral degree
- Patient monitoring
- English
- Health insurance
Quick apply
Safety & PV Specialist II (Night Shift)
サイネオス・ヘルス —Hyderabad, Telangana
- Night shift
- Medicine
- B.Sc
- Master's degree

I want to receive the latest job alerts for clinical trials project management in hyderabad telangana

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

clinical trials project management jobs near hyderabad telangana

Senior Data Analyst jobs in Hyderabad, Telangana

Data Engineer jobs in Hyderabad, Telangana

Event Manager jobs in Hyderabad, Telangana

Product Owner jobs in Hyderabad, Telangana

Biostatistician jobs in Hyderabad, Telangana

Logistics Associate jobs in Hyderabad, Telangana

Implementation Specialist jobs in Hyderabad, Telangana

Data Analyst jobs in Pune, Maharashtra

Senior Data Analyst jobs in Nashik, Maharashtra

Data Entry,work From Home jobs in Kollam, Kerala

Senior Data Analyst jobs in Andheri, Mumbai, Maharashtra

Senior Data Analyst jobs in Chennai, Tamil Nadu

Senior Data Analyst jobs in Remote

Senior Accountant jobs in Pune, Maharashtra

Data Engineer jobs in Baner, Pune, Maharashtra

Work From Home Network Engineer jobs in Maharashtra

Data Engineer jobs in Thane, Maharashtra

Data Engineer jobs in Kochi, Kerala

Data Entry jobs in Nehru Place, Delhi, Delhi

Electrical Engineer jobs in Aurangabad, Maharashtra

Senior Regulatory Medical Writer

Jeevan -
Hyderabad, Telangana

Apply Now

Job details

Qualifications

Microsoft Powerpoint
Microsoft Word
Medicine
Doctoral degree
B.Sc
Writing skills
Adobe Illustrator
Windows
Master's degree
Science
Project management
Bachelor's degree
Pharmacy
Document management systems
Communication skills
Editing

Full job description

Job description

The Regulatory Medical Writer-Clinical trials (RMW-CT) is responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) as designated by leadership. The RMW provides support for the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests using available reference materials such as documentation of previous interactions with HAs and sponsor, clinical development documentation, scientific literature, and content provided by sponsor team. The RMW may be the lead contact for sponsor or designated HAs interactions with cross functional teams contributing to the preparation of submission materials, including project and timeline management activities. The RMW is responsible for ensuring the accuracy and quality of submission-ready documents using established and effective sponsor and/or internal writing processes. The RMW partners with the sponsor/HAs leadership to prepare high-quality, accurate and concise documentation supporting the objectives of sponsor/HAs teams and leadership.

Responsibilities Include:

RMW serves as the regulatory lead representative on project teams by partnering with the JSTL outsourcing and operational teams including functional area contributors (eg, Clinical, Data Management, etc.) to prepare a high-quality, clearly-messaged documents founded in regulation and supported by the science. These documents include but not limited to Clinical Study Reports (CSR), Clinical Summaries, Clinical Responses, and Protocol Summaries for submission to the sponsor and/or HAs.
Must be highly competent to understand the Clinical Trial Protocol elements including study designs, data analysis, timelines and patient recruitment. Coordinate the review, approval, QC, and other appropriate functions involved in the production of regulatory projects.
Arrange and conduct review meetings with the team.
Independently resolve document content issues and questions arising during the writing process.
Prepare scientific communications for external publication in peer-reviewed journals and presentations at scientific congresses. These documents include manuscripts, abstracts, posters and oral presentations
RMW provides leadership and project management expertise for ongoing programs and/or projects and initiatives.
Ensure accurate and timely completion/delivery of information and review of regulatory submissions to the sponsor or its designee.
Communicate regularly with JSTL leadership on timeline/milestone progress for any assigned program.
Assess resource needs as timelines progress and communicate any addition resource requests to department management team.
Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH, CDSCO) and other governing bodies by following applicable divisional guidelines, templates, and standard operating procedures (SOPs).
Proactively identify and implement tactical process improvements.
Mentor and provide guidance and oversight to support staff including other participating writers and/or external vendor resources and agencies.

Job Requirements and Qualifications :

Educational qualifications:

A minimum of a Bachelor of Science in life sciences with significant relevant writing experience.
A relevant advanced degree (e.g. MS Pharmacy, PharmD, PhD, MD) is preferred, and higher education may compensate for years of experience.
A certificate in regulatory affairs and/or medical writing is highly preferred.
Minimum of 2-4 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia required, or in a related area such as quality, regulatory, clinical research (Phase I-IV), or product support/R&D.
Good understanding of clinical development processes including principles of clinical study operations, ICH-GCP guidelines, and IJME guidelines.
High-level content writing experience and experience with clinical development regulatory documents required, with working knowledge of statistical concepts and techniques.
Excellent written and oral communication skills.
Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience.
Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
Peer-review and editing skills are a plus.
Knowledge and expertise with Common Technical Document (CTD) content templates, electronic document management systems and information technology.
Excellent working knowledge of software programs in Windows environment including MS Word/ PowerPoint/ Excel, and Adobe Illustrator

Apply Now

Refine Your Search

clinical trials project management jobs in hyderabad telangana

Senior Regulatory Medical Writer

Manager, CSAR – Custom function Programming

Biostatistical Programming Senior Associate

Senior Director, Integration and Digital Data Flows

Principal Biostatistician (VAX)

Biostatistical Programming Mgr

Customer Support Engineer

IT Delivery Lead - Technology IT

Senior Principal Clinical Programmer (Medidata RAVE)

Manager, Commercial AI Product Owner

Medical Monitor

Senior Workforce Data Analyst

Specialist IS Engineer - System Implementation & Development

Global HEOR Evidence Synthesis Manager

Sr. Manager, Data Governance Lead – Domain Specific

Senior Data Engineer

Business Controls Function (BCF) Automation Manager

Manager, Logistics

Clinical Translation Executive

Safety & PV Specialist II (Night Shift)

I want to receive the latest job alerts for clinical trials project management in hyderabad telangana

Explore jobs in more locations

Jobseeker tools

Employer Tools

Browse

Stay Connected