Expert Regulatory Writer
2 hours ago
392687BR
**Expert Regulatory Writer**:
India
**About the role**
Position Title: Expert Regulatory Writer
About the role: Expert Regulatory Writer
Location - Hyderabad #LI Hybrid
The number of regulatory documents we authored last year. As an Expert Regulatory Writer you will develop documents which cover all Novartis therapeutic areas and therapies, ranging from Phase I to IV Clinical Study Reports to regulatory submission documents (e.g. Clinical Summaries, Clinical Overview, Briefing Books, answers to Health Authority Questions) for New Drug Applications (NDA), supplemental NDAs, Marketing Authorization Applications and Type II variations.
Key responsibilities:
- To author, review and lead high quality clinical and safety documents: Complex Clinical Study Reports (CSR), Risk Management Plans (RMP), Complex Common Technical Document (CTD) submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities.
- Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines.
- Ad-hoc member of Clinical Trial Team and extended member of Safety Management Team. Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical Teams (GCT).
- Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions.
- Documentation expert in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines.
- Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents. Coach and/or mentor less experienced writers & lead in cross-functional communication to optimize feedback and input towards high quality documents.
**Commitment to Diversity & Inclusion**:
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Role Requirements**
Minimum Life Science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
- 6 + years medical regulatory writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus experienced knowledge of medical writing processes.
- Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
- Excellent communication skills (written, verbal, presentations). Fluency in English is essential.
- Shown ability to prioritize and lead multiple demands and projects.
- Experience in leading global, cross-functional teams or complex global projects. Demonstrated ability to motivate and coach people.
You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
**Division**
Development
**Business Unit**
GCO GDD
**Work Location**
Hyderabad, AP
**Company/Legal Entity**
Nov Hltcr Shared Services Ind
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
-
Regulatory Writer
7 days ago
Hyderabad, Telangana, India Novartis Full time900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...
-
Regulatory Writer
2 days ago
Hyderabad, Telangana, India Novartis Full time900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...
-
Regulatory Writer
4 weeks ago
Hyderabad, Telangana, India Sandoz Full timeJob DescriptionMajor accountabilities:- To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).- 2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.- 3. Core member of Clinical Trial Team (CTT) /...
-
Cmc regulatory expert
4 weeks ago
Hyderabad, Telangana, India BeBeeRegulatory Full timeJob Title: Chemistry, Manufacturing and Control Regulatory Expert -We are seeking an experienced Chemistry, Manufacturing and Control (CMC) Regulatory Expert to join our team. This is a challenging role that requires a strong understanding of regulatory requirements and the ability to lead global CMC submission activities. The ideal candidate will have...
-
Medical Writer
1 week ago
Telangana, India Makrocare Full time**MakroCare** is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical,- Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New- Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,- Medical/Scientific Support and Emerging Region Expansion**Job...
-
Director Global Regulatory Writing
4 weeks ago
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionIt is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.- Prepare and oversee the review and approval of...
-
Intermediate Writer
2 hours ago
Hyderabad, Telangana, India Innovatia Inc. Full timeInnovatia Content Solutions is an industry leading content solutions provider with expertise in the Information Technology, Telecommunications, and Energy sectors. Operating for over 20 years, we provide our customers enterprise content solutions to address business challenges while meeting the needs of their end users. We accomplish this through learning...
-
Content Writers
2 hours ago
Telangana, India Mr. M Technologies Full timeWe are looking for young passionate content writer cum SEO experts who can create fresh content on educational, recruitment and entertainment topics. We will be required 80% contents on education niches i.e. Educational, Recruitment, Entertainment and News topics. If you are a student and need a pocket money? Then join us as a part time employee. We will...
-
Proposal Writer
2 weeks ago
Srinagar colony, Hyderabad, Telangana, India Ashray Akruti Full timeSalary will be negotiable Job responsibilities: - Develop and write proposals for new scientific contracts and programs - Work with internal teams to gather information and develop concepts - Have a strong understanding of the regulatory landscape in the pharmaceutical industry - Have excellent time management skills - Work with therapeutic and operational...
-
Senior Medical Writer II
2 days ago
Hyderabad, Telangana, India ProPharma Full time ₹ 8,00,000 - ₹ 24,00,000 per yearFor the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...
