Expert Regulatory Writer

5 months ago


Hyderabad Telangana, India Novartis Full time

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



  • Hyderabad, Telangana, India Lifelancer Full time

    About this RoleWe are seeking a highly skilled Senior Regulatory Content Expert to join our team at Lifelancer. In this role, you will be responsible for creating and editing high-quality clinical and safety documents for submission to regulatory authorities.Key Responsibilities:Write and/or edit complex Clinical Study Reports (CSR), CTD submission...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Transforming Lives through Innovative ScienceBristol Myers Squibb is a global biopharmaceutical company that is committed to making a meaningful difference in the lives of patients. We are seeking a highly skilled Senior Scientific Writer to join our team in Hyderabad.Job SummaryThe successful candidate will be responsible for coordinating and authoring...

  • Medical Writer

    4 weeks ago


    Hyderabad, Telangana, India ClinChoice Full time

    Clinical Documentation SpecialistAt ClinChoice, we are seeking a highly skilled Clinical Documentation Specialist to join our team. As a key member of our medical writing team, you will be responsible for creating, editing, and coordinating the production of clinical and regulatory submission documents.Key Responsibilities:Research and create clinical...

  • Content Writers

    5 months ago


    Telangana, India Mr. M Technologies Full time

    Mr. M Technologies offers a selections for Web Designers, Web Developers, Responsive Web Designers, Content Writers, SEO Experts and Website Maintainers. We can provide you jobs with good rates while you can choose what you want based on your experience We are looking for young passionate content writer cum SEO experts who can create fresh content on...

  • Medical Writer

    5 months ago


    Madhapur, Hyderabad, Telangana, India Makrocare Full time

    **Company Description**: **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...


  • Hyderabad, Telangana, India Base8 Inc Full time

    **Who We Are**: Base8 provides technology and business consulting services to companies throughout the US and Canada under the XOverture, Cure8, and Forte brands. We like to work with businesses that are serious about scaling, risk management, and developing mature processes - ones that are looking for a modern, sophisticated, trustworthy, friendly,...


  • Hyderabad, Telangana, India Lifelancer Full time

    About the CompanyLifelancer is a leading talent-hiring platform specializing in Life Sciences, Pharma, and IT. We connect exceptional professionals with opportunities in pharmaceuticals, biotechnology, health sciences, healthtech, and IT domains.Job Title and DescriptionThe ideal candidate will hold a senior position as a Regulatory Medical Writer, focusing...

  • Content Writers

    5 months ago


    Telangana, India Mr. M Technologies Full time

    We 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...


  • Hyderabad, Telangana, India Lifelancer Full time

    Job TitleRegulatory Affairs Expert - Enhanced Regulatory ComplianceAbout the RoleThis exciting opportunity is part of a globally inclusive and diverse company, Eastman Chemical Company. As a Regulatory Affairs Expert, you will be responsible for resolving complex regulatory challenges and initiatives for Eastman's product portfolio.Your primary focus will be...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Bristol Myers Squibb is a global biopharma leader driven by a mission to transform patients' lives.Estimated Salary: $120,000 - $180,000 per yearAbout the RoleWe are seeking an experienced Regulatory Submission Manager to join our team in Hyderabad. The successful candidate will be responsible for managing and coordinating the timely, compliant, and accurate...

  • R&d Regulatory Affairs

    2 months ago


    Hyderabad, Telangana, India PepsiCo Full time

    Overview: - This role involves supporting the Regulatory Affairs team by serving as a Discipline Approver, ensuring compliance with regulatory standards for raw material specifications. Located within the Mexico Business Services or Hyderabad Business Services, you will play a key part in maintaining adherence to regulations within the designated business...

  • Medical Writer

    2 months ago


    Madhapur, Hyderabad, Telangana, India MakroCare Clinical Research Ltd 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 NewDimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,Medical/Scientific Support and Emerging Region Expansion **Job...

  • Content Writer

    3 months ago


    Hyderabad, Telangana, India VisaPro Full time

    **VisaPro: Jobs in Hyderabad, India Office**: Best Place For The Best People To Work **Content Writer (Code: IN126)**: **VisaPro Content Writer will**: - Be trained in content management, and business process flow development. - Write articles and prepare reports & white papers. - Ensure that content meets editorial style, consistency, and accuracy...

  • Intermediate Writer

    5 months ago


    Hyderabad, Telangana, India Innovatia Inc. Full time

    Innovatia 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...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. As a Biostatistics Expert with a focus on regulatory requirements, you will play a crucial role in shaping the future of drug development and delivery.Salary: $120,000 - $180,000 per yearAbout the...


  • Hyderabad, Telangana, India ProcessQ Tecnologies Full time

    Job Title: Senior Technical Writer - Content ExpertJob Summary:We are looking for a skilled Technical Writer to produce top-notch documentation for our software products. As a Senior Technical Writer, you will work closely with our development team to create user-friendly and accurate documentation.Responsibilities:Write high-quality technical documentation...

  • Medical Writer II

    1 month ago


    Hyderabad, Telangana, India Parexel Full time

    Job Title: Medical Writer IIParexel is seeking a highly skilled Medical Writer II to join our team. As a Medical Writer II, you will be responsible for creating high-quality medical content for regulatory submissions, clinical study reports, and other pharmaceutical industry documents.Key Responsibilities:Develop and maintain a strong understanding of...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Transforming Lives through Innovative DocumentationBristol Myers Squibb is a global leader in the pharmaceutical industry, and we're seeking a talented Senior Scientific Writer to join our team. As a Senior Scientific Writer, you will play a critical role in the development of complex documents needed for regulatory submissions, ensuring the coordination and...


  • Hyderabad, Telangana, India SBCLLP Full time

    Job Title: SEZ Compliance Officer - Regulatory ExpertJob Summary:The SEZ Compliance Officer - Regulatory Expert will be responsible for ensuring compliance with Special Economic Zone (SEZ) regulations. This role involves overseeing monthly SEZ processes, facilitating the transition between SEZ premises, and coordinating with various departments to ensure...

  • Content Writer

    2 months ago


    Kondapur, Hyderabad, Telangana, India Branding Experts Full time

    This is a full-time role for a Content Writer at Branding Experts. As a Content Writer, you will be responsible for web content writing, content strategy, research, writing, and proofreading. Your day-to-day tasks will involve creating engaging and compelling content that aligns with brand objectives and attracts target audiences. This is an on-site role...