Global Clinical Publishing Associate
20 hours ago
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 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 minimal 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 Skills Desired Data Analysis Document Management Life Science Project Management Regulatory Compliance
-
Global Clinical Publishing Associate
3 days ago
Hyderabad, Telangana, India Novartis Full timeSummary 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 Publishing Specialist
21 hours ago
Hyderabad, Telangana, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000Job Title: Clinical Publishing SpecialistClinical publishing specialists play a vital role in ensuring the quality and compliance of clinical documents. As a member of our team, you will be responsible for compiling and adding electronic navigation to clinical and regulatory documents. Your attention to detail and ability to work independently will be...
-
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionRoles & Responsibilities:- Lead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans.- Participation in information system and software update projects as well as ongoing system validations- Serve as point of contact between Amgen's functional contributors and external...
-
Global Clinical Operations Specialist
7 days ago
Hyderabad, Telangana, India beBeeClinicalOperations Full time ₹ 1,43,11,756 - ₹ 2,17,17,991Transforming clinical operations to enhance life outcomes is a key objective of this role.About The PositionAnalyze various data sources, including trial results, historical performance, publications, epidemiology, and commercial landscape insights.Provide strategic modeling and viability analysis to inform early recruitment projections and clinical trial...
-
Hyderabad, Telangana, India Amgen Inc Full timeJob DescriptionLead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans.- Participation in information system and software update projects as well as ongoing system validations.- Serve as point of contact between Amgen's functional contributors and external partners, to ensure smooth...
-
Clinical Research Associate Specialist
5 days ago
Hyderabad, Telangana, India beBeeResearch Full time ₹ 9,00,000 - ₹ 12,30,000About this role:We are seeking a clinical research associate to join our team.Key Responsibilities:AUTHOR and analyze clinical trial documents, working with key clinical documents like protocol, informed consent form, clinical study report, summary of clinical safety/efficacy, access evidence dossier, statistical analysis plan, and more.Create, validate, and...
-
Clinical Trials Coordinator
5 days ago
Hyderabad, Telangana, India beBeeProgram Full time ₹ 2,00,00,000 - ₹ 2,50,00,000Global Clinical Operations Program Manager RoleThis position offers the opportunity to become a key member of our clinical operations team, overseeing and coordinating early modeling viability assessments, global feasibility assessments, recruitment projections, and allocation strategies for assigned trials and programs.About The RoleThe ideal candidate will...
-
Global Clinical Research Specialist
5 days ago
Hyderabad, Telangana, India beBeeClinicalResearch Full time US$ 80,000 - US$ 1,25,000**Job Overview:**We are seeking a skilled professional to join our team as a Clinical Research Specialist. In this role, you will be responsible for contributing to the operational execution of clinical studies and supporting complex global trials.**Key Responsibilities:Collaborate with cross-functional teams to execute on assigned operational aspects of...
-
Associate Clinical Trial Leader
4 weeks ago
Hyderabad, Telangana, India Thepharmadaily Full timeJob DescriptionResponsible for supporting, under the guidance of the Lead Clinical Trial Leader and/or Clinical Trial Leader (CTL) and the Clinical Program Leader (CPL), all aspects of TCO clinical trial(s) as assignedMajor accountabilities:- May lead studies in maintenance or in closeout phase or ongoing studies post primary database lock with the oversight...
-
Clinical Publishing Specialist
3 days ago
Hyderabad, Telangana, India beBeePublisher Full time ₹ 80,00,000 - ₹ 1,50,00,000Job OverviewWe are seeking a skilled publishing professional to join our team in a critical role that requires strong technical expertise and effective communication skills. Key Responsibilities:
