Regulatory Writer
1 month ago
900 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 to bring innovative medicines to patients worldwide. You will collaborate with colleagues from Statistics, Data Management and Clinical Development and have the opportunity to analyze data and derive key messaging to secure approvals from Health Authorities. Read on for details about the role and how you can join a world-class organization at the forefront of the industry to advance your career.
Your responsibilities include, but are not limited to:
- 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). Core member of clinical Trial Team/participate in safety Management Team.
- Actively participate in planning of data analyses and presentation used in CSRs.
- Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- May Act as Program Writer ensuring adequate medical writing resources are available for assigned Program and consistency between documents.
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
- 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
- Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
- Knowledge of process for and some experience in global registering of drugs (simple submissions).
- Excellent communication skills (written, verbal, presentations). Very good understanding of biostatistics principles.
WHY NOVARTIS
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying Imagine what you could do here at Novartis
**Division**
Global Drug Development
**Business Unit**
GCO GDD
**Country**
India
**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
1 month ago
Hyderabad, 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...
-
Group Head
5 days ago
hyderabad, India Novartis Full timeAbout the role : Group HeadLocation – Hyderabad #LI HybridPosition Purpose:-To write, review and manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative documentation-related consultancy to other line functions. To coach, mentor and...
-
Group Head
6 days ago
Hyderabad, India Novartis Full timeAbout the role: Group HeadLocation – Hyderabad #LI HybridPosition Purpose:-To write, review and manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative documentation-related consultancy to other line functions. To coach, mentor and train...
-
Technical Writer
1 week ago
Hyderabad, India Collabera Full timeJob Description:We are seeking a 5+ Years experienced Technical Writer to join our team.As a Technical Writer, you will play a crucial role in creating high-quality documentation that contributes to the overall success of our products.You'll collaborate with internal teams, including developers, quality engineers, product managers, and usability...
-
Technical Writer
1 week ago
hyderabad, India Collabera Full timeJob Description:We are seeking a 5+ Years experienced Technical Writer to join our team.As a Technical Writer, you will play a crucial role in creating high-quality documentation that contributes to the overall success of our products.You'll collaborate with internal teams, including developers, quality engineers, product managers, and usability experts, to...
-
Technical Writer
1 week ago
Hyderabad, India Collabera Full timeJob Description:We are seeking a 5+ Years experienced Technical Writer to join our team.As a Technical Writer, you will play a crucial role in creating high-quality documentation that contributes to the overall success of our products.You'll collaborate with internal teams, including developers, quality engineers, product managers, and usability...
-
Content Writer
1 week ago
hyderabad, India Zenwork, Inc Full timeAre you passionate about crafting compelling content that resonates with businesses? Do you have a knack for distilling complex topics into engaging narratives? If so, Zenwork Inc. is looking for you!Zenwork Inc., the parent company of Tax1099 and backed by Spectrum Equity, is a pioneer in digital tax compliance and regulatory reporting technology. With over...
-
Content Writer
1 week ago
Hyderabad, India Zenwork, Inc Full timeAre you passionate about crafting compelling content that resonates with businesses? Do you have a knack for distilling complex topics into engaging narratives? If so, Zenwork Inc. is looking for you! Zenwork Inc., the parent company of Tax1099 and backed by Spectrum Equity, is a pioneer in digital tax compliance and regulatory reporting technology. With...
-
15h Left: Content Writer
2 days ago
Hyderabad, India Zenwork, Inc Full timeAre you passionate about crafting compelling content that resonates with businesses? Do you have a knack for distilling complex topics into engaging narratives? If so, Zenwork Inc. is looking for you!Zenwork Inc., the parent company of Tax1099 and backed by Spectrum Equity, is a pioneer in digital tax compliance and regulatory reporting technology. With over...
-
Manager - CSR Writing
1 month ago
hyderabad, India ClinChoice Full timeManager - CSR Writing Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Primary Responsibilities: The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety...
-
Manager - CSR Writing
1 month ago
Hyderabad, India ClinChoice Full timeManager - CSR Writing Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Primary Responsibilities: The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety update...
-
Securities Operations Representative
1 week ago
Hyderabad, Telangana, India Wells Fargo Full time**About this role**: Wells Fargo is seeking a Senior Securities Operations Representative. **In this role, you will**: - Perform a variety of operational tasks for complex securities or process extensive knowledge of systems. - Provide ideas for improving or implementing processes. - Perform moderately complex duties such as processing, researching...
-
Medical Writer I
3 hours ago
Hyderabad, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews...
-
Scientific Writer II
3 weeks ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Procedure Writer
2 hours ago
Hyderabad, India WELLS FARGO BANK Full timeAbout this role:"Wells Fargo is seeking a (insert job title). We believe in the power of working together because great ideas can come from anyone. Through collaboration, any employee can have an impact and make a difference for the entire company. Explore opportunities with us for a career in a supportive environment where you can learn and grow." In this...
-
Senior Scientific Writer I
3 weeks ago
Hyderabad, India Bristol Myers Squibb Full timeWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Scientific Writer I
1 day ago
Hyderabad, Telangana, India Bristol Myers Squibb Full timeWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Safety Writer
1 month ago
Hyderabad, India Novartis Full time2600+ Aggregate Reports annually! Dynamic teams at Novartis are committed to scientifically evaluate benefit-risk profile of the marketed products and collaborate with Health Authorities towards the ultimate goal of Patient Safety. Your skills & experience will help us on our journey of re-imagining patient safety. - Your responsibilities include, but are...
-
Quality Control Editor
1 month ago
Hyderabad, India ProPharma Group Full timeFor 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. As the world’s largest RCO (Research Consulting Organization), ProPharma partners...
-
Product Manager- US Payroll
2 days ago
hyderabad, India Oracle Full timeAs a premier part of Oracle’s cloud solutions, the SuitePeople team at NetSuite enjoys a small company culture with the added benefits of the strength and stability of a global organization. Our work environment is open and agile. We thrive on collaboration and global teamwork to build a seamlessly integrated suite of features and flexible solutions...