Clinical Dossier Lead Consultant
vor 19 Stunden
**Clinical Dossier Lead Consultant**
**Location**: Basel
**Contract**: 6-month, with potential for extension
**Start Date**: ASAP
**Workload**: Full-time
**Overview**:
Our client, a Swiss pharmaceutical company specializing in medicines for rare diseases, is seeking an experienced Clinical Dossier Lead Consultant. This role involves leading the update and submission of major regulatory dossiers.
**Key Responsibilities**:
- Lead the update of major regulatory dossiers.
- Extract, interpret, and integrate clinical data from several study reports, ensuring consistency and accuracy.
- Collaborate with and provide direction to medical writers for summary of safety, clinical overview, and other key documentation.
- Evaluate long-term safety data for an already submitted dossier and incorporate findings into updated submissions.
- Act as the lead for clinical submissions, ensuring compliance with regulatory standards for NDA and MAA filings.
- Address challenges in the existing dossier structure and improve document quality for clarity and coherence.
- Partner with internal and external teams to align on submission strategies and timelines.
**Required Qualifications**:
- Advanced degree in life sciences, medicine, or a related field.
- Extensive experience (8+ years) in regulatory affairs, clinical science, or related roles, with a focus on dossier preparation and submissions.
- Proven track record of leading NDA and MAA submissions in the pharmaceutical/biotech industry.
- Ability to navigate and improve poorly structured dossiers with a critical, problem-solving mindset.
- Strong analytical, data interpretation, and regulatory writing skills.
- Excellent communication and leadership skills, with experience guiding cross-functional teams.
headcount AG
-
Clinical Trial Leader I
Vor 7 Tagen
Basel, Schweiz Novartis Vollzeit6000! That’s the number of associates in the Novartis Institutes for BioMedical Research (NIBR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients! Based on our understanding of cancer at the molecular, cellular and organismal levels,...
-
Clinical Transparency Lead
vor 2 Wochen
Basel, Schweiz Idorsia Pharmaceuticals Ltd. VollzeitAbout Idorsia Pharmaceuticals Ltd Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients. In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core. Headquartered in Switzerland - a European biotech hub -...
-
Clinical Science Lead
vor 8 Monaten
Basel, Schweiz Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Clinical Trial Lead
vor 2 Wochen
Basel, Schweiz Source Group International VollzeitXplore Life Science are currently seeking an experienced Clinical Trial Leader to oversee the planning an implementation of a new study conducted by a class leading pharmaceuticals company based in Basel, Switzerland. Duration of assignment is approx 18 months with potential for extension. Major Accountabilities: - Function as Clinical Trial Leader for...
-
Associate Clinical Trial Leader
Vor 3 Tagen
Basel, Schweiz Novartis Vollzeit6000! That’s the number of associates in the Novartis Institutes for BioMedical Research - (NIBR). This division is the innovation engine of Novartis, focusing on powerful new - technologies that have the potential to help produce therapeutic breakthroughs for patients! - Based on our understanding of cancer at the molecular, cellular and organismal...
-
Clinical Research Study Leader
Vor 5 Tagen
Basel, Schweiz Global Kader Personal Vollzeit**EINFÜHRUNG**: As a preferred supplier for Roche Basel, we are looking for an individual as **Clinical Research Study Leader (M/F/d)**: (contract for 1 year, with possible extension). Start date is asap or within 2 months. Remote/Home Office: At least three days a week on-site. **AUFGABENBESCHREIBUNG**: - Leads the cross-functional Study Management...
-
Global Clinical Leader Ophthalmology
vor 2 Wochen
Basel, Schweiz Bayer Vollzeit**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Clinical Trial Leader
Vor 5 Tagen
Basel, Schweiz CTC Resourcing Solutions Vollzeit**The Life Science Career Network** Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a...
-
Lead Clinical Scientist, Immunology
vor 3 Stunden
Basel, Schweiz F. Hoffmann-La Roche Gruppe VollzeitThe PositionWe advance science so that we all have more time with the people we love.The Roche/Genentech Product Development Clinical Science organization is structured by therapeutic area and is responsible for developing and executing the late-stage development (Phase 2-3) clinical strategies and plans to deliver medically differentiated therapies that...
-
Lead Clinical Scientist, Immunology
Vor 3 Tagen
Basel, Schweiz Roche VollzeitThe PositionWe advance science so that we all have more time with the people we love.The Roche/Genentech Product Development Clinical Science organization is structured by therapeutic area and is responsible for developing and executing the late-stage development (Phase 2-3) clinical strategies and plans to deliver medically differentiated therapies that...
-
Digital Biomarker Clinical Integration Lead
vor 1 Monat
Basel, Schweiz F. Hoffmann-La Roche Gruppe VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Team Lead Clinical Bioanalysis
vor 2 Wochen
Basel, Schweiz Haybury VollzeitAt a pivotal moment for the department, a rare new opportunity has become available with one of the world’s pioneers in the pharmaceutical industry, as the Associate Director of Clinical Bioanalysis, supporting their first-in-class pipeline of molecules including many niche modalities including cell and gene therapies and oligonucleotides. This role brings...
-
Clinical Development Medical Director
Vor 7 Tagen
Basel, Schweiz Haybury Vollzeit*Clinical Development Medical Director - Basel, Switzerland* 12-month full-time contract Flexible working model Looking for a talented professional to join one of the largest global pharmaceutical companies as a Clinical Development Medical Director, to be part of a diverse team at the forefront of innovation. What the role involves: - Oversight of the...
-
Lead Clinical Research Scientist, Metabolism
vor 1 Woche
Basel, Schweiz Genentech VollzeitThe PositionWe advance science so that we all have more time with the people we love.The OpportunityThe Roche/Genentech Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late stage development (Phase 2-3) clinical strategies and plans to deliver medically differentiated therapies that...
-
Cmc Dossier Manager
Vor 5 Tagen
Basel, Schweiz Sobi Vollzeit**Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **CMC Dossier...
-
Digital Biomarker Clinical Integration Lead
vor 1 Monat
Basel, Schweiz Roche VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Regional Clinical Operations Lead
Vor 7 Tagen
Basel, Schweiz Proclinical VollzeitProclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion. Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of...
-
Clinical Program Leader
vor 7 Monaten
Basel, Schweiz Novartis Vollzeit**About the Role**: 6000! That's the number of associates in the BioMedical Research (BR). This division is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients! Based on our understanding of cancer at the molecular, cellular and organismal levels,...
-
Clinical Pharmacology Lead
Vor 4 Tagen
Basel, Schweiz Bayer Sverige VollzeitAt Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none' is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Clinical Pharmacology Lead
Vor 3 Tagen
Basel, Schweiz Bayer CropScience Limited VollzeitAt Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...