Global Clinical Publishing Associate

1 week ago

Hyderabad Telangana, India Novartis Full time

**Summary**:
Ensure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs), and provide publishing consultancy to the clinical teams and other line functions.

**About the Role**:
Key Responsibilities
- In collaboration with the clinical teams, compile, integrate and publish clinical documents with word processing, electronic publishing, and document management systems in the Novartis Development environment.
- Perform technical quality control (electronic functionality, adherence to internal and external document standards) of published documents.
- Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements.
- Under direct supervision of the immediate manager, acts as the Program Publisher for various programs in clinical development.
- Publish clinical documents (taking into account complexity and size) in accordance with department standards and organization KPIs.
- Ensure published clinical documents meet current internal and external quality standards for electronic and/or paper HA submissions, including minimizing publishing-related technical QC findings and no rework once finalized.
- Timeliness of deliverables meet both individual document and overall project timelines.

Minimum Requirements
- 3-5 years submission publishing experience in Pharma or related industry.
- Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria.
- Effective interpersonal skills, strong written and oral communication and presentation skills.
- Project management and time management skills to manage multiple ongoing projects simultaneously.
- Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives.
- Working knowledge of regulatory affairs, works independently and with mínimal supervision.
- Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly.
- Analytical skills and problem solving skills, ability to coordinate and work effectively with cross-functional teams.

Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation

Division

Development

Business Unit

Universal Hierarchy Node

Location

India

Site

Hyderabad (Office)

Company / Legal Entity

IN10 (FCRS = IN010) Novartis Healthcare Private Limited

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

**Accessibility and accommodation**:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

  • Global Clinical Publishing Associate

    3 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Summary Ensure compliance with internal and external guidelines to compile and add electronic navigation to clinical and regulatory documents Support the timely submission of documents to the Health Authorities HAs and provide publishing consultancy to the clinical teams and other line functions Key Responsibilities In collaboration with the clinical teams...

  • Global Clinical Publishing Associate

    1 day ago

    Hyderabad (Office), India Novartis Full time ₹ 4,50,000 - ₹ 9,00,000 per year

    BandLevel 3Job Description SummaryEnsure compliance with internal and external guidelines, to compile and add electronic navigation to clinical and regulatory documents. Support the timely submission of documents to the Health Authorities (HAs) and provide publishing consultancy to the clinical teams and other line functions.Job DescriptionMajor...

  • Global Trial Acceleration Associate

    1 week ago

    Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    **Working 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...

  • Global Trial Acceleration Associate

    1 week ago

    Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    **Working 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...

  • Associate Clinical Study Manager

    4 weeks ago

    Hyderabad, Telangana, India Novartis Full time

    Summary LI-Hybrid Location Hyderabad India Step into a role where your expertise drives innovation in clinical research As an Associate Clinical Study Manager you ll play a pivotal part in shaping the future of patient care by ensuring our studies are executed with precision quality and compassion At Novartis your contributions will directly impact lives and...

  • Clinical Trials Disclosure Associate

    2 days ago

    Hyderabad, Telangana, India Amgen Full time

    **Clinical Transparency & Disclosure Associate** **Role Name**:Clinical Transparency & Disclosure Sr. Associate **Department Name**:Global Regulatory Affairs & Strategy (GRAAS) **Role GCF**:3 **Hiring Manager Name**:Jennifer Vande Weghe **ABOUT AMGEN** Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make...

  • Global Trial Acceleration Associate

    11 hours ago

    Hyderabad, Telangana, India Bristol-Myers Squibb Full time

    Working 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 the lives of...

  • Clinical Scientific Expert I

    1 week ago

    Hyderabad, Telangana, India Novartis Full time

    **Summary**: - Contributes, with appropriate oversight, to all relevant aspects of global clinical trial(s) activities to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial(s). Core member of the Clinical Trial Team. -Applicable to Clinical Scientific Expert IThe...

  • Clinical Research Associate

    1 week ago

    Greater Hyderabad Area, India Admerus Biosciences Private Limited Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Company DescriptionAdmerus Biosciences, headquartered in Hyderabad, India, is a Contract Research Organization (CRO) that services the global Biopharma industry. We partner with reputed global biopharma and research laboratories to find efficient, cost-effective, and innovative solutions to their clinical development challenges. Our focus is on delivering...

  • Apprentice - Editorial, Design & Publishing

    2 days ago

    Hyderabad, Telangana, India S&P Global Full time

    **About the Role**: **Grade Level (for internal use)**: 05 **The Role**: We are looking for an apprentice for a period of 12-months in our Editorial, Design & Publishing Team, responsible for branding and editorial support on S&P Global Market Intelligence content. The main focus is to maintain and enhance the quality and consistency of editorial content by...