Regulatory Affairs Consultant

**Required education**: Degree in relevant life science discipline **Required Experience**: 2-4 years relevant experience **Required Technical Skills**: - Lifecycle maintenance experience - Providing support during external and unannounced audits. - Responding to internal requests for technical and/or regulatory information. - Preparation and submission...

The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the regulatory project team members (regulatory affairs, eTMF operations). The RPA also supports activities within the regulatory website Clinical Trial Information System (CTIS) ensuring completeness and timely entry of information for EU submissions. The...

**Responsibilities**: - Preparation and submission of EU Marketing Authorisation Applications (Module 1,2,3) for Initial MAA and LCM (via DCP, MRP and NP) - Monitor and maintain up-to-date knowledge of national and European guidelines/legislation. - Ensuring compliance with all regulatory processes including MHRA and HPRA - Management of artwork...

**Responsibilities**: - To contribute to the production of client administrative documents and reports to be included in regulatory submissions - Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements - LCM, Systems Management and Administration - Document and track regulatory submissions and regulatory...

**Description** **Medical Writer II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...

Job Overview Engage in peer-to-peer scientific exchange with ability to understand, interpret, communicate complex scientific data and information effectively to KOLs/HCPs Essential Functions - Engage in peer-to-peer scientific exchange with ability to understand, interpret, communicate complex scientific data and information effectively to KOLs/HCPs -...

Responsibilities:Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required.Proactively...

Key Accountabilities:Project Management: Ability to fill Statistical Programming Lead role on projects -Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. -Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.-Monitor project resourcing, project...

**1. Distribution**: - Output clients’ copy in timely fashion - Ensure accurate distribution to correct circuit at specified time. - Monitor and chase return of requested translations for onward distribution. - Upload graphics and linked documents onto PR Newswire for Journalists, and the PR Newswire websites **2. Editorial**: - Ensure accuracy,...

Key Accountabilities:Project Management: Ability to fill Statistical Programming Lead role on projects -Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to. -Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.-Monitor project resourcing, project...

**Description** **Principal Statistical Programmer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...

**Department** Just about anyone seeking published literature to answer research questions can type terms into a database and then hope to make sense of the information retrieved. But when done without the right knowledge, skills, and experience, such an exercise risks answers that are biased, confusing, incomplete, or wholly incorrect. This helps explain...

**About Neolytix** Neolytix is a boutique Consulting and Management Services Organization that works with small & medium-sized healthcare providers across the United States. Our portfolio of services caters to micro verticals and is built on the expertise we have developed in enabling these practices. Work with a company where your work can make a real...

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As a member of Parexel’s Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and...

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Overview We are looking for a corporate lawyer to serve as an in-house counsel and handle all legal transactions, partnerships, projects, and employee related matters pertaining primarily to our North American entities. Your principal goal will be to guarantee that all our company’s transactions comply with state laws and regulations, and to advise our...

At Zappy, we support innovation by discovering faster, better, and more productive ways to conduct business. We are a startup factory! And we are on a mission to fundamentally add value to the business community by creating tech-driven alternatives that improve their operations. We build start-ups that help businesses solve existing constraints and address...

**Description** **Associate Director, Biostatistics** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to...