Job Summary: 

• As a Product Developer in the Better Health Vitamins, Minerals, and Supplements Division, you will be responsible for dietary supplement product innovations. 
• Serve as a thought leader and product developer, recommending product and ingredient ideas to translate and deliver against end-user insights.
• Survey available clinical data and/or recommend and oversee the appropriate clinical trial work necessary for claim substantiation. 
• Work on innovation teams in close partnership with Packaging and Process peers, as well as Marketing, Sales, Product Supply, and Regulatory. 
• Play a significant role in driving innovation for the Better Health VMS Division. 
• Training trial collaborators in the management of study data and documentation, animal ethics applications, data capture forms and study folders and clinical supplies.
• Managing trials including but not limited to: relationship with study site/collaborators & internal colleagues, data collection and analysis, collection, preparation and assay of samples, monitoring clinical trials and documentation of protocol deviation/amendment.
• May lead project/functional team or subteam.
• Contributing to operational initiatives to improve the overall function of the VMRD group.

Skills on Resume:

• Product Innovation (Hard Skills)
• Thought Leadership (Soft Skills)
• Clinical Data Analysis (Hard Skills)
• Cross-functional Collaboration (Soft Skills)
• Trial Management (Hard Skills)
• Team Leadership (Soft Skills)
• Training Development (Hard Skills)
• Operational Improvement (Hard Skills)

Job Summary: 

• Establish and execute a Clinical Evidence Roadmap 
• Initiate or pursue and grow collaborations 
• Prepare clinical protocols, and synopses, to become scientific publications 
• Review clinical documents, plans and tables, listings and figures 
• Review, analyze, and interpret data based on scientific proof, in line with the industry standards 
• Prepare scientific abstracts, posters, and manuscripts 
• Create high-quality documents, seeking excellence in scientific content, organization, clarity, accuracy as well as statistical analysis 
• Monitor publications and trends in the Interventional space 
• Provide technical and operational leadership, and support the development of medicinal products. 
• Responsible for program and study level scientific, medical and operational activities during protocol development, trial execution, and read-out in compliance with internal processes, GCP/ICH and regulatory requirements.

Skills on Resume:

• Roadmap Execution (Hard Skills)
• Collaboration Development (Soft Skills)
• Protocol Preparation (Hard Skills)
• Data Analysis (Hard Skills)
• Scientific Writing (Hard Skills)
• Trend Monitoring (Hard Skills)
• Technical Leadership (Soft Skills)
• Regulatory Compliance (Hard Skills)

Job Summary: 

• Participate in and assist in the planning of scientific advisory boards
• Plan, participate and present at investigator meetings and ad-hoc meetings
• Prepare and present clinical data at internal and external scientific advisory board meetings 
• Understanding of Good Clinical Practices, pharmacovigilance standards, and all other quality standards in conducting research.
• Collaborate with the project physician and the biostatistician in the interpretation of data and the creation of analysis plans
• Support clinical study execution, including participating in site selection, vendor management, investigator meetings, internal and external collaborations 
• Participate in the creation of clinical development plans with the project physician including the provision of strategic scientific input 
• Collaborate with data management and clinical operations to ensure the appropriate collection and cleaning of clinical data
• Operates in collaboration with and under the supervision of the study and/or program MD.
• Conduct regular reviews of listings

Skills on Resume:

• Event Planning (Hard Skills)
• Presentation Skills (Soft Skills)
• Clinical Data Interpretation (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Analysis Planning (Hard Skills)
• Study Execution Support (Hard Skills)
• Strategic Planning (Soft Skills)
• Data Management (Hard Skills)

Job Summary: 

• Collaboration with the project physician, perform regular data reviews of individual and aggregate subject data and monitor compliance and data quality
• Assessment of inclusion and exclusion criteria, patient medical history, concomitant medications, study endpoints, protocol deviations, and laboratory parameters
• Partner with Data Management, Biostatistics, and the project medical director/clinical lead-in for the creation of CRFs, CRF completion guidelines, data review plan, medical review plan, and data listings
• Contribute to the review, analysis, and interpretation of study results, including exploratory endpoints and assuring appropriate data review 
• Collaborate with data management and clinical operations in the management of issues with data reporting
• Author or contribute to the scientific writing for documents in whole or in part including protocols and amendments, clinical study reports, investigator’s brochure, regulatory documents including briefing books and DSUR, meeting abstracts and scientific publications
• Conduct searches and reviews of the scientific literature, and stay current on therapeutic area practice standards and guidelines
• Collaborate with the project physician to direct the planning and implementation of clinical programs to meet corporate and clinical research goals
• Assist in establishing project budgets and Standard Operating Procedures, and reviewing ongoing study data including safety, primary efficacy variables, and laboratory data
• Prepare deliverables for periodic review meetings and participate in Study Management Team meetings

Skills on Resume:

• Data Review (Hard Skills)
• CRF Development (Hard Skills)
• Data Analysis (Hard Skills)
• Scientific Writing (Hard Skills)
• Literature Review (Hard Skills)
• Clinical Program Planning (Hard Skills)
• Budget Management (Hard Skills)
• Team Collaboration (Soft Skills)

Job Summary: 

• Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations to Medical Director, Rare Diseases.
• Support accurate preparation of scientific material for conference presentations, publications, as well as any internal or external scientific communication related to the clinical studies or mechanism of action of the study drug
• Provide support to advisory boards, consultant meetings, and investigator meetings, including preparation and delivery of presentations under the guidance of the Medical Director, Rare Disease.
• Build strong cross functional relationships with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives
• Respond to or triage questions for appropriate escalations.
• Support authoring and review of protocols, clinical study reports, Investigator Brochure, Informed Consent Form, training documents, charters, and other clinical and regulatory documents.
• Proactively recommend and implement process improvements to minimize the risk of error, preserve data integrity, optimize cross functional interactions internally, and improve functional efficiency.
• Analyze and generate information to assess issues relating to protocol conduct and/or individual patient safety. 
• Assist in communicating a clear overview of trial results. 
• Support Medical Director, Rare Disease with safety reviews, site interactions and review of tables and data listings.

Skills on Resume:

• Data Analysis (Hard Skills)
• Scientific Communication (Hard Skills)
• Presentation Delivery (Soft Skills)
• Stakeholder Relationships (Soft Skills)
• Protocol Authoring (Hard Skills)
• Process Improvement (Hard Skills)
• Safety Assessment (Hard Skills)
• Data Review (Hard Skills)

Job Summary: 

• Responsible for drafting key clinical trial documents in collaboration with Clinical Operations, Biostats, Medical Writing and the CROs
• Supports the medical monitoring of efficacy, safety and laboratory data received from the clinical trials
• Works directly with the investigational sites to ensure a seamless exchange of support and information during the study work up, ongoing trials, and closure
• Responsible for the clinical aspects of the Data Review Plan
• Support the analysis and drafting of clinical trials and scientific publications
• Works closely with Clinical Operations and Data Management for CRF design
• Supports investigational site start ups and will present on behalf of Clinical Development
• Ensure the TMF is completed for Clinical development requirements
• Support the running and operational aspects of the Clinical Development team including meeting support, inspection readiness, and organizational support
• Participate in open-source competitive intelligence and/or other market/industry assessment activities and projects.

Skills on Resume:

• Document Drafting (Hard Skills)
• Medical Monitoring (Hard Skills)
• Site Communication (Soft Skills)
• Data Review Planning (Hard Skills)
• Data Analysis (Hard Skills)
• CRF Design (Hard Skills)
• Presentation Skills (Soft Skills)
• Organizational Support (Soft Skills)

Job Summary: 

• Applying scientific expertise in the design of clinical studies in accordance with clinical the development strategy
• Contributing to the development of key study documents, including but not limited to study protocols, clinical sections of the investigator brochure and patient informed consents
• Ensuring that insights obtained from external stakeholders (key opinion leaders, healthcare providers, investigators, investigational site study staff, patients/patient groups…) guide clinical trial design and protocol development
• Supporting real world evidence and historical data initiatives to help drive decision making
• Performing clinical data reviews, in collaboration with the VP of Pharmacovigilance and VP of Clinical Strategy, ensuring appropriate input from Data Safety Monitoring Board and/or Clinical Event Committee
• Contributing to clinical sections of regulatory documents (e.g., NDA, MAA, IND, IB, briefing packages) and supports written and oral regulatory interactions from a clinical perspective
• Collaborating with the Clinical Team leader (CTL) and other members of the study team to review key study metrics (e.g. enrollment data, patient retention rates, screen fail rates, protocol deviations) and to determine appropriate actions
• Assisting with the identification and selection of investigational sites and supports the sites during the conduct of the study in close collaboration with other members of the study team
• Assisting with the identification, selection and training of vendors to support clinical studies

Skills on Resume:

• Clinical Study Design (Hard Skills)
• Document Development (Hard Skills)
• Stakeholder Engagement (Soft Skills)
• Data Analysis (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Team Collaboration (Soft Skills)
• Site Selection Support (Hard Skills)
• Vendor Training (Hard Skills)

Job Summary: 

• Hold primary responsibility in the planning and preparation for animal trials 
• Working with relevant stakeholders to develop study design, identification of experimental fish, preparation of study protocols and reports, training trial collaborators in the management of study data and documentation, animal ethics applications.
• Managing trials including but not limited to: relationship with study site/collaborators & internal colleagues, data collection and analysis, preparation and assay of samples, conducting and monitoring clinical trials and documentation of protocol deviation/amendment.
• May lead project/functional team or sub-team.
• Attendance at Project Team meetings and contribution to discussions.
• Some of maintenance work for recirculating aquaculture system (RAS), a state of art system for fish rearing.
• Contributing to operational initiatives to improve the overall function of the aqua team and wet-lab facility.
• Assisting with inspection readiness activities for assigned clinical trials
• Contributing to/participating in the development, review, and training of SOPs.

Skills on Resume:

• Trial Planning (Hard Skills)
• Study Design (Hard Skills)
• Data Management (Hard Skills)
• Sample Assay (Hard Skills)
• Team Leadership (Soft Skills)
• System Maintenance (Hard Skills)
• Operational Improvement (Soft Skills)
• SOP Development (Hard Skills)

Job Summary: 

• Support the preparation of key clinical documents to be prepared for clinical trials from phase 1 (excluding healthy volunteers) to Phase 3
• Contribute to preparation and/or review of any documents related to the clinical study and requiring a scientific background: Abbreviated protocol, protocol (and amended protocol), ICF, presentation/communication to internal and external partners, study plans, Protocol Registration Form, study report
• Contribute to the preparation of interactions with Sanofi internal governance bodies, external partners, key opinion leaders, investigators, and preparation of answers to Health Authorities /IRB
• Contribute to the medical input provided to the CRF review/design with regards to adequacy with protocol, CRF Completion Instructions, and in the preparation/review of other study documents as delegated by CRD
• When needed, and as delegated by CRD, support activities to study set up (feasibility, medical support materials, site initiation, document submission, etc)
• Collaborate with the study conduct under the guidance of CRD in the medical review of data listings, patient profiles, deviations, and the interaction with coding specialist, biostatistician, GSM, RTM, Pharmacovigilance representative, medical writer
• Support to the CRD ensuring appropriate documentation and consistency of safety cases in collaboration with appropriate stakeholders
• Support the CRD in the preparation/conduct of the committees involved in the study: study board, Steering committee or Data monitoring committee, adjudication committee
• Support CRD in the completion of the study trial master file

Skills on Resume:

• Document Preparation (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Data Analysis (Hard Skills)
• Research Design (Hard Skills)
• Stakeholder Communication (Soft Skills)
• Team Collaboration (Soft Skills)
• Problem Solving (Soft Skills)
• Project Management (Soft Skills)