Medical Device Regulatory and Clinical Affairs

**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...

**Responsibilities**: - Contribute to regulatory activities performed on the RA Platform/the Hub. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions. - To contribute to the production of client administrative documents to be included in regulatory submissions -...

**Description** **Principal Medical Writer** 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...

(India) Looking for experienced regulatory writers **As we are expanding our team, we are thrilled to announce that we are looking for experienced Indian regulatory writers to join our dynamic, collaborative team to engage with biopharmaceutical clients and prepare clinical and safety regulatory documents. This is a full-time, remote, salaried...

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 -...

Job Description:Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets with focus on EU countries.Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissionsKnowledge of EU country regulationsAble to...

Medical Communications **Designation ** Writer - Medical Communications - Docplexus is one of the largest and fastest growing online platforms for doctors in the world. **Company **With over 3,80,000 doctors in its community, Docplexus focuses on peer-to-peer exchange of patient cases, dialogue, and interdisciplinary learning to improve medical outcomes....

**Job Title: Medical Writer (1-2 Years Experience)** **Responsibilities**: - Create precise medical content following scientific and regulatory guidelines. - Conduct thorough research on medical topics. - Prepare regulatory documents like clinical study reports and protocols. - Assist in manuscript development for scientific journals. - Collaborate with...

**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...

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What you will be doing**: Serve as a Clinical Data reviewer and identify any errors in data by...

**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...

Clinical Trial Protocol SpecialistThe Clinical Trial Protocol Specialist will research, create, and edit clinical trial protocols as well as provide expert support for protocol development.Operates as a lead medical writer or as a Subject Matter Expert (SME) to support Medical Writers and Clinical Trial Services management, as well as other Parexel...

Job Overview Acts as Lead Medical Writer on more advanced writing projects (e.g. complex clinical study reports, protocols, more challenging indications, or customers). Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. May provide feedback to peers when...

Job DescriptionProvides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Demonstrates subject matter and therapeutic area expertise. May assist program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient...

Job Purpose: Responsible for management of scheduled and unscheduled aggregate reports including but not limited to Periodic Safety Reports (PSRs) including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Semi-Annual Safety Reports (SASRs), Corporate Addendum Reports, United...

**Medical Writer to**: 1. Draft Informed Consent Forms for patients joining clinical trials in English. 2. Draft patient information (posters, leaflets and letters) about clinical trials Life Science Degree essential. Some experience writing for patients preferred.

**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...

**Job Title**: Clinic Assistant Intern (Intern to Full-Time) - English Speaking **Company**: 24/7 DCT **Location**: Remote - India **About Us**: 24/7 DCT is a leading provider of online healthcare services, committed to revolutionizing the way individuals access and receive medical care. Through our innovative telehealth platforms and virtual clinics, we...

Major duties and responsibilities: - oversees the Medical Review (MR) of ICSRs as per predefined activity and job-role in PV safety database, with special focus on case medical accuracy and documentation, - maintains overall accountability for the timeliness and quality of medical case management activities outsourced to service providers, - leads or...

We are looking for experienced Indian clinical trial disclosure associates to join our dynamic, collaborative team to engage with biopharmaceutical clients to prepare and maintain clinical trial registry postings across global registries. This a full-time, remote opportunity. **About Us** Kateric (a Propharma group company) is a strategic partner for...