Global Clinical Publishing Associate
3 weeks 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
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Global Clinical Publishing Associate
3 weeks 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...
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Senior Associate, Global Submission Management
4 weeks ago
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...
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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...
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Hyderabad, Telangana, India Makrocare Full time ₹ 6,00,000 - ₹ 12,00,000 per yearEducation: Bachelors Degree in Life Sciences or related fieldMarkets: US/UK/EU/ROW Job Summary:We are seeking a detail-oriented and proactive Associate - Regulatory Affairs (RA) Publishing with 1-3 years of experience in regulatory submissions across global markets including the US, UK, EU, and ROW (Rest of World). The ideal candidate will have a background...
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Global Trial Acceleration Associate
24 hours ago
Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 12,00,000 - ₹ 36,00,000 per yearWorking 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...
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Global Trial Acceleration Associate
2 days ago
Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 12,00,000 - ₹ 36,00,000 per yearWorking 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...
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Global Heor Value Writing Senior Associate
3 weeks ago
Hyderabad, Telangana, India Amgen Full timeCareer Category Health Economics Global HEOR Value Writing Senior Associate Department Global Health Economics Outcomes Research HEOR Job Family Health Economics Job Type Full-Time Location Hyderabad India Reports To Global Value Writing Team Lead Position Summary The Global HEOR Value Writing Senior Associate plays a critical role in...
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Clinical Data Associate II
1 week ago
Hyderabad, Telangana, India Statistics & Data Corporation (SDC) Full time ₹ 9,00,000 - ₹ 12,00,000 per yearClinical Data Associate IIStatistics & Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical...
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Hyderabad, Telangana, India Bristol Myers Squibb Full time ₹ 6,00,000 - ₹ 12,00,000 per yearWorking 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...
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Sales Associate
1 day ago
Hyderabad, Telangana, India V K Global Publications. Pvt. Full time ₹ 3,00,000 - ₹ 6,00,000 per yearCompany DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time on-site role for a Sales Associate at V K Global Publications Pvt. Ltd. in Hyderabad. The Sales Associate will be responsible for managing customer accounts, generating leads, negotiating sales deals, and providing excellent customer service. The role will also involve...
