Regulatory Writer

392687BR **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,...

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...

Regulatory Writer OpportunityWe are seeking an experienced regulatory writer to join our team.The ideal candidate will have a strong background in scientific/technical writing and editing, as well as experience with complex standard operating procedures (SOPs), guidance documents, and work instructions.Responsibilities include authoring and gaining approval...

Regulatory Writing Professional">Authored regulatory documents, including Clinical Study Reports, Investigator Brochures, and eCTD Module 2 Clinical Summary Documents.Conducted formal reviews and approvals of authored documents following standard operating procedures.Managed regulatory writing activities for product submissions, including new and...

Job DescriptionMajor accountabilities:- To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).- 2. Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.- 3. Core member of Clinical Trial Team (CTT) /...

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...

Regulatory Writing Manager Job DescriptionThis role involves overseeing the creation and approval of regulatory documents, ensuring compliance with applicable standard operating procedures. The successful candidate will have significant experience in scientific/technical writing and editing, as well as a strong understanding of clinical development...

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 Title: Global Regulatory Writing LeaderAbout the Role:We are seeking a professional to oversee the preparation and review of scientific and regulatory submission documents. The successful candidate will serve as a functional area lead on product teams, maintain key business relationships with cross-functional team members, and provide expertise in...

**Who We Are**: Base8 provides technology and business consulting services to companies throughout the US and Canada under the XOverture, Cure8, and Forte brands. We like to work with businesses that are serious about scaling, risk management, and developing mature processes - ones that are looking for a modern, sophisticated, trustworthy, friendly,...