Regulatory Writing Manager

Job Title: Regulatory Writing Specialist\ Job Summary: We are seeking a skilled Regulatory Writing Specialist to join our team. This role involves creating high-quality documents for regulatory submissions, including clinical study reports, observational research study reports, and plain language summaries. The successful candidate will have excellent...

Job DescriptionRoles & Responsibilities:- Author regulatory submission documents, as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, Pediatric...

Regulatory Writing Manager Job Description:Job Summary:We are seeking an experienced Regulatory Writing Manager to lead the development and submission of regulatory documents. The successful candidate will have a strong background in scientific and technical writing, as well as excellent leadership skills.Key Responsibilities:

Job DescriptionIt is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us.- Prepare and oversee the review and approval of...

Career Category RegulatoryRoles and Responsibilities Performs document-level QC including abbreviations references to sources data in text versus data in tables figures or graphs etc to ensure submission readiness quality Ensures the consistency and accuracy of layouts fonts margins styles and spacing logical content organization and proper...

Job DescriptionRoles and Responsibilities- Performs document-level QC (including abbreviations, references to sources, data in text versus data in tables, figures, or graphs, etc.) to ensure submission readiness quality- Ensures theconsistencyandaccuracyof layouts, fonts, margins, styles, and spacing, logical content organization, and proper use of headings,...

Job Title: Director Global Regulatory WritingDescriptionWe are seeking a skilled and experienced professional to lead our regulatory writing efforts. The successful candidate will have a strong background in scientific writing, editing, and analysis, as well as excellent leadership and communication skills.ResponsibilitiesPrepare and oversee the review and...

Job DescriptionIn this vital role, you will author and gain approval of scientific and regulatory submission documents that align with global regulatory standards. To maintain key business relationships with appropriate cross-functional product team members. As requested, this role may serve as functional area lead on product teams, manage (with supervision)...

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...

Career CategoryRegulatoryJob DescriptionABOUT AMGENAmgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years...