לוח משרות דרושים מנהל פרויקטים ברפואה ופארמה משרה מלאה, לחיפוש זה נמצאו 20 משרות

Accountable for developing and implementing plans to effectively demonstrate and communicate the clinical and economic value of products to internal and external customers.

Acting as a functional leader for market access activities that include, but are not limited to, assessing market access needs/trends, and developing and executing required market access strategies to optimize market access, adoption, and commercial success.

Contributing to annual brand planning by providing robust analysis and a strong payer value proposition and to forecasting, business planning, pricing, and budgeting processes

Create and develop quantitative business cases to support contracting efforts.

Key Responsibilities:

Strategy Development:

Develop and implement comprehensive market access strategies aligned with the company's business objectives in Israel.
Conduct assessments of the local healthcare environment, payer landscape, and regulatory requirements to inform strategy development.
Collaborate with cross-functional teams to integrate market access considerations into product development and commercialization plans.
Identify opportunities and potential risks related to market access and develop mitigation strategies.
Reimbursement and Pricing:

Lead the submission and negotiation process for product reimbursement with relevant governmental authorities and health insurance industry in Israel. The Market Access Director Responsible to plan and lead all aspects of Health basket process and coordinate the cross-functional team for timely preparation to secure NHB inclusion.
Design and execute the PRA (Pricing & Reimbursement Affairs) Governance and the PRA Roadmap.
Develop pricing strategies to maximize product value while ensuring affordability and market competitiveness.
Setting optimal pricing and contracting strategy per market segments
Conduct pricing and reimbursement analyses, including health economic evaluations, to support pricing and reimbursement decisions.
Stay updated on pricing and reimbursement regulations and guidelines in Israel and provide guidance to internal stakeholders.
Acting as a functional leader for market access activities that include, but are not limited to, assessing market access needs/trends, and developing and executing required market access strategies to optimize market access, adoption, and commercial success.
Ensuring robust pricing practices, tendering, contracting protocols and operations to ensure efficient and compliant organization.
Contributing to annual brand planning by providing robust analysis and a strong payer value proposition and to forecasting, business planning and budgeting processes
Demonstrate competency in the use of business analytics to evaluate profit/loss of business deals.
Create and develop quantitative business cases to support contracting efforts in partnership with Affiliate finance team.

The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs. This opportunity is an exciting prospect for a big pharma company and for a new division focused on Oncology/Cell therapy.




What You'll Do:
Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.

The Clinical Trial Manager is accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. The Clinical Trial Manager interprets data on project issues and makes good business decisions with support from experienced team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. The position involves working on projects of low to moderate complexity and as part of a team of CTMs in Israel.


What You'll Do:
Manage all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less complex projects.
Develop clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contribute to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensure timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborate with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings.
Collaborate with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicate with the team and lead team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department.
Ensure achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitor or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials.
May communicate with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues.
May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensure that essential document quality meets the expectation of Regulatory Compliance Review. Review and follows up on all questions raised by the ethics committees.
May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements.