Global Clinical Publishing Associate

6 months 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**:
**Major accountabilities**:

- 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.

**Key performance indicators**:

- 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**:

- 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 guidance, 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.

**Work Experience**:

- Cross Cultural Experience.
- Functional Breadth.
- Collaborating across boundaries.
- Operations Management and Execution.
- Project Management.

**Skills**:

- Clinical Study Reports.
- Data Analysis.
- Documentation Management.
- Lifesciences.
- Operational Excellence.
- Regulatory Compliance.

**Languages**:

- English.

Division

Development

Business Unit

Pharmaceuticals

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

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



  • 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...


  • Hyderabad, India Makro Full time

    Position:Associate RAPublishingLocation:Hyderabad Madhapur Telangana500081ExperienceRequired: 13YearsEducation:Bachelor s Degree in Life Sciences or relatedfieldMarkets:US/UK/EU/ROWJobSummary:We are seeking adetailoriented and proactive Associate Regulatory Affairs (RA)Publishing with 13 years of experiencein regulatory submissions across global markets...


  • Hyderabad, Telangana, India Novartis Full time

    **Summary**: - Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in...


  • Hyderabad, Telangana, India Makrocare Full time

    **Job Summary**: **Key Responsibilities**: - Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various markets including the US, UK, EU, and ROW. - Ensure submissions are compliant with the regulatory guidelines and are ready for on-time dispatch. - Manage and track the status of submissions and respond to regulatory agencies'...


  • Hyderabad, Telangana, India MAKRO Full time

    **Job Summary**: **Key Responsibilities**: Prepare, review, and compile regulatory submissions in eCTD/aCTD formats for various markets including the US, UK, EU, and ROW. Ensure submissions are compliant with the regulatory guidelines and are ready for on-time dispatch. Manage and track the status of submissions and respond to regulatory agencies' queries...


  • Hyderabad, Telangana, India Novartis Full time

    **Summary**: - Support QC/completeness checks on all global TCO study TMFs in accordance with Novartis SOPs, working practices and ICH/GCP Guidelines. Follow-up with the CTT to resolve quality issues identified and escalate potential SOP/WP deviations.. - Maintain up to date knowledge of the TMF Reference Model. Support documentation of appropriate...


  • Hyderabad District, Telangana, India Novartis Full time

    7000 patients, 1200 clinical sites, 40 countries, 100+ clinical studies led by Novartis Clinical Sciences & Innovation (CS&I) last year. Who are we? We are Clinical Sciences and Innovation at Novartis. A dynamic group of Clinical Scientists who plan and execute early phase trials worldwide in general medicine. From First-in-Human to Proof-of-Concept and...


  • Hyderabad, Telangana, India Novartis Full time

    **Summary**: “150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs...


  • 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...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Bristol Myers Squibb (BMS) is a leading global biopharmaceutical company with a rich history of innovation and commitment to improving patient lives. With a diverse portfolio of innovative medicines, vaccines, and medical devices, BMS is dedicated to addressing some of the world's most pressing health challenges.About This RoleWe are seeking an experienced...


  • Hyderabad, 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...


  • Hyderabad, India Ferring Pharmaceuticals Full time

    Job Description:Role: Associate Director – Bio-clinical studiesReporting to: Senior Director - Pharmaceutical DevelopmentLocation: HyderabadExperience: At least 15 years of industrial experience in the following:Drug product development in early to late phase clinical development.Hands on experience in BA-BE studies in healthy volunteers.Hands on...


  • Hyderabad, India Novartis Full time

    387199BR **Associate Medical Expert**: India **About the role** Associate Medical Expert Location - Hyderabad #LI Hybrid About the Role: The Associate Medical Expert will ensure the successful implementation and delivery of the Medical and Knowledge Solutions (MKS) scientific and medical services along the business colleagues’ requirements. He/ she is...


  • Hyderabad, Telangana, India Bristol Myers Squibb Full time

    Position Summary:This individual contributor role has task-level responsibility for clinical trial related document collection, compilation, review and approval across all phases of global clinical trials. This may also include review of all the Site Monitoring Visit reports, issue escalation, resolution and follow up tasks.Key ResponsibilitiesThe Document...


  • Hyderabad, Telangana, India Manasvini Global Solutions Full time

    **Location**: Hyderabad, India **Position Overview**: **Key Responsibilities**: - **SAS Programming**: Develop and maintain SAS programs for clinical data analysis, validation, and reporting purposes. Generate summary tables, listings, and graphical presentations as per study requirements. - **Data Management Support**: Collaborate with cross-functional...


  • Hyderabad, Telangana, India Zeta Global Full time

    **Digital Marketing Associate** **Summary** Zeta's Marketing Operations team is comprised of over 50 individuals across different geo locations who provide world class operational support of shared services to the stakeholders and clients of Zeta using multiple in-house and commercial performance marketing tools. We are currently looking for a **Digital...


  • Hyderabad, India Dr Reddy's Laboratories Limited Full time

    Job DescriptionJob Summary The Clinical Trial Associate (CTA) supports clinical studies and the Clinical Operations Department, in managing various administrative tasks such as generation of agenda and minutes, maintaining study tracking, filing and quality reviews as well as participating to process improvement initiatives across the departments. Roles &...


  • 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...


  • Hyderabad, India Tech Observer Full time

    Tech Observer is a Global CRO and FSP solution provider with HO in NJ, USA and presence in other 20+ countries. Tech Observer is an equal opportunity employer.Job Location : Mumbai/Ahmedabad/HyderabadBrief Responsibilities ( but not limited to)• Responsible for efficient planning, designing ,development and maintenance of clinicaldatabase management...

  • Clinical Psychologist

    19 hours ago


    Hyderabad, Telangana, India Mpower Full time

    Role: - Psychologist ( choose any one) Location: - Hyderabad, Telangana Educational Qualification: - M.Phil in Clinical Psychology Years of Experience: - 3 to 8 years experience after completion of M.Phil or Psy D in Clinical Psychology will also do. **Salary**: - As per Industry Standards **Duties and Responsibilities: - ** 1. Conduct client...