Safety Writer

Perform allied activities such as data collection for report planning, developing strategy, and leading kick-off meetings and round table discussion for comment resolution.  Write various safety reports (or part of such reports) for global regulatory submissions, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports,...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

393319BR **Expert Regulatory Writer**: India **About the role** Position Title: Expert Regulatory Writer About the role: Expert Regulatory Writer Location - Hyderabad #LI Hybrid The number of regulatory documents we authored last year. As an Expert Regulatory Writer, you will develop documents which cover all Novartis therapeutic areas and therapies,...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

900! That is the approximate number of individual regulatory documents the dynamic team at Regulatory Writing and Submissions (RWS) planned, developed and wrote. And that’s just in 2019! Come, join a global team of nearly 200 regulatory professionals - life scientists, clinicians and project managers across 6 countries and support Novartis in its mission...

JOB DESCRIPTION Purpose of Position:  The Technical Writer creates technical communication media that includes, but is not limited to instructions, user guides, configuration manuals, help systems, and other documents that comply with the approved documentation standards. The Technical Writer takes inputs from SMEs from different domains to produce...

Job responsibilities Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables Ensure compliance of operations with governing regulatory requirements Create, maintain and assume accountability for a...

**MAIN PURPOSE OF ROLE** - Leads/supervises a team of 2 or more professionals. - First level manager of a work team that could comprise professionals, technical and/or administrative staff. - Typically without budget or hire/fire authority. - Focuses on mentoring, coaching, and coordination. **MAIN RESPONSIBILITIES** - Responsible for the company's drug...

Efficiency in conducting literature searches for authoring various types of reports  Author/review various safety reports for global regulatory submissions for Lab Corp clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and...

Write and review various safety reports (or part of such reports) for global regulatory submissions for Sciformix’s clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Bridging reports  Write Investigator brochures and sections of protocols  Write Clinical Study Reports (in...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical...

Architect I - Mumbai Department: MMB01 - Mumbai Studio 01 Location: Mumbai, MUM Job ID: 1353 Salary: $0 - $0 Employee Referral Bonus: Employee Referral Eligible Life at PE: Perkins Eastman is a global design firm with expertise that covers all aspects of the built environment. With studios in 24 locations worldwide, we design for...

Architect I - Mumbai Department: MMB01 - Mumbai Studio 01 Location: Mumbai, MUM Job ID: 1353 Salary: $0 - $0 Employee Referral Bonus: Employee Referral Eligible Life at PE: Perkins Eastman is a global design firm with expertise that covers all aspects of the built environment. With studios in 24 locations worldwide, we design...

What impact will you make?  Every day, your work will make an impact that matters, while you thrive in a dynamic culture of inclusion, collaboration and high performance. As the undisputed leader in professional services, Deloitte is where you’ll find unrivaled opportunities to succeed and realize your full potential.  The Team  The Marketing,...