Current jobs related to Associate Director, Clinical Regulatory Writing - Bangalore - AstraZeneca
-
Associate Director, Clinical Regulatory Writing
3 months ago
bangalore, India AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...
-
bangalore, India AstraZeneca Full timeAt AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. Recognizing the importance of individualized flexibility, our ways of working allow employees to balance...
-
Manager - Clinical Regulatory
3 months ago
Bangalore, India AstraZeneca Full timeJOB TITLE : - CLINICAL REGULATORY CAREER LEVEL: D Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug...
-
Manager - Clinical Regulatory
4 days ago
bangalore, India AstraZeneca Full timeJOB TITLE : - CLINICAL REGULATORY CAREER LEVEL: D Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug...
-
Manager - Clinical Regulatory
3 months ago
bangalore, India AstraZeneca Full timeJOB TITLE : - CLINICAL REGULATORY CAREER LEVEL: D Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug...
-
Associate Director/Director of Development
1 week ago
bangalore, India Allucent Full timeAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are re seeking a highly skilled and experienced Associate Director/Director of Development to join our A-team (hybrid*). As an Associate...
-
Associate Director/Director of Development
4 days ago
bangalore, India Allucent Full timeAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are re seeking a highly skilled and experienced Associate Director/Director of Development to join our A-team (hybrid*). As an Associate...
-
bangalore, India Vertex Full timeJob Description General Summary: The Associate Director, Global Clinical Distribution Quality role will work with the GMP Operational QA team to ensure that medicines are distributed in compliance with GDP and GMP requirements for Clinical Distribution. Key Duties and Responsibilities: Lead Clinical Quality Distribution team to support the Clinical...
-
bangalore, India Vertex Full timeJob DescriptionGeneral Summary:The Associate Director, Global Clinical Distribution Quality role will work with the GMP Operational QA team to ensure that medicines are distributed in compliance with GDP and GMP requirements for Clinical Distribution.Key Duties and Responsibilities:Lead Clinical Quality Distribution team to support the Clinical Supply Chain...
-
Manager - CSR Writing
4 days ago
bangalore, India ClinChoice Full timeManager - CSR Writing Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Primary Responsibilities: The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety update...
-
Manager - CSR Writing
4 months ago
bangalore, India ClinChoice Full timeManager - CSR Writing Full-Time Bengaluru, Karnataka, India Hyderabad, Telangana, India Description Primary Responsibilities: The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety...
-
Senior Medical Writer
3 weeks ago
bangalore, India MS CLINICAL RESEARCH Full timeJob Title : Senior Medical WriterCompany : MS ClinicalLocation : BangaloreJob Type : Full-timeAbout MS Clinical :MS Clinical is a dynamic and innovative company dedicated to advancing medical research and improving patient outcomes. We specialize in conducting clinical trials and providing comprehensive medical writing services to pharmaceutical,...
-
Senior Medical Writer
2 weeks ago
Bangalore, India MS CLINICAL RESEARCH Full timeJob Title : Senior Medical Writer Company : MS Clinical Location : Bangalore Job Type : Full-time About MS Clinical : MS Clinical is a dynamic and innovative company dedicated to advancing medical research and improving patient outcomes. We specialize in conducting clinical trials and providing comprehensive medical writing services...
-
Associate Director, Regulatory Affairs
2 weeks ago
bangalore, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Key Responsibilities Clinical Trial Regulatory Submissions : Over 15 years of relevant experience in clinical trial regulatory submissions. Regulatory Leadership : Experience in managing clinical trial studies, serving as Regulatory Lead for global trials, with exposure...
-
Associate Director, Regulatory Affairs
4 days ago
bangalore, India Parexel Full timeWhen our values align, there's no limit to what we can achieve. Key Responsibilities Clinical Trial Regulatory Submissions : Over 15 years of relevant experience in clinical trial regulatory submissions. Regulatory Leadership : Experience in managing clinical trial studies, serving as Regulatory Lead for global trials, with exposure to the...
-
Clinical Data Manager
3 days ago
bangalore, India George Clinical Full timeWe are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...
-
Bangalore, India AstraZeneca Full timeJob Title: International CMC RA Associate Director I Career Level - E Introduction to Role: Join us at AstraZeneca as an International CMC RA Associate Director and play a critical role in impacting patients in need. In this role, you will have the opportunity to utilize your expertise in CMC Regulatory Strategy, Operational, tactical, and...
-
Clinical Data Manager
4 months ago
bangalore, India George Clinical Full timeWe are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of...
-
Clinical Data Manager
2 weeks ago
Bangalore, India George Clinical Full timeWe are expanding! We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow. Who are we? A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence 20+ years of...
-
Lead Regulatory Affairs
4 days ago
bangalore, India Halma plc Full timeAbout Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialise in market leading technologies that push the...
Associate Director, Clinical Regulatory Writing
4 months ago
JOB TITLE : Associate Director- Clinical Regulatory Writing
CAREER LEVEL: E
Lead the way for a new breed of solutions-oriented Regulators
Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get involved in shaping drug development
Be part of the team where you are empowered to follow the science
Be part of the solution, turning our drug development strategies into reality. Work at all stages of development to translate our life-changing science into medicines to get the best results for AstraZeneca, patients in need and healthcare professionals..
About Astrazeneca
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development
About the team
We are a diverse and open-minded team harnessing our different skills and experiences. As a Regulatory function we use our capabilities to accelerate discovery and development. Combining knowledge from across our Therapy Areas helps us to deliver rapid and global approvals that bring new medicines to patients.
About the role
Role holders provide strategic leadership and communications expertise to clinical drug programs. They author clinical-regulatory documents and provide critical review to achieve high quality standards. They represent the skill on drug and non-drug projects
Typical Accountabilities
The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company’s core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving critical communication excellence to achieve successful submissions and approvals.
The Clinical Regulatory Writing Associate Director is expected to:
• Independently handle clinical regulatory writing activities across a complex portfolio of work.
• Author the most complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied.
• As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
• When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS).
• Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality.
• Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements.
• Be a strategic problem solver and demonstrate strategic review capabilities.
• Proactively collaborative with other functions at the program level.
• Support the development of Clinical Regulatory Writing Managers.
• Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required.
Education, Qualifications, Skills and Experience
Essential
• Life Sciences degree in an appropriate field.
• Significant medical writing experience in the pharmaceutical industry or CRO.
• Ability to advise and lead communication projects.
• Understand drug development and communication process from development, launch through life cycle management.
• In depth knowledge of the technical and regulatory requirements related to the role.
Desirable
Advanced degree in a scientific discipline (
WHY JOIN US ?
We believe there’s always a better way of doing things. Committed to finding improvements that will impact patients with serious diseases, we are always asking questions, trying new things and sharing new proposals.
Our advanced approach to Regulatory means we are leading the field. We get to work closely with drug development to influence early on and continue to make valuable contributions throughout
SO, WHAT’S NEXT?
Are you already envisioning yourself joining our team? Good, because we’d love to hear from you Click the link to apply and we’ll be in touch as soon as we can.
WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.
Date Posted
14-May-2024Closing Date
08-Jun-2024