Director of Medical Affairs; Hematology /Coagulation-Near Jersey City
Purpose of this Position
The Director, Medical Affairs, Hematology/Coagulation will have accountability and responsibility in the management of field-based medical activity across the Coag Portfolio. The position will be responsible for establishing and fostering professional relationships with key opinion leaders ensuring access to current medical and scientific information on company products and hematology/coag therapeutic areas of interest. The position will also provide medical/scientific expertise and support to global and commercial functions within the organization via effective scientific exchange.
Essential Functions
- Support the development and maintenance of strong academic and stakeholder relationships both internally and externally via effective scientific exchange
- Partner with global colleagues for product/research development projects and strategy
- Collaborate and contribute in the design and development of medical/scientific presentation materials, training, and educational programs
- Develop strategies and tactics to accommodate academic, clinical, and scientific support for advisory boards, congresses, conventions, symposia, etc.
- Identify and develop internal medical affairs information technology platforms to enhance efficiency
- Respond in a timely and effective manner to medical and product information requests
- Provide internal and external scientific training/presentations
- Track all information requests and responses and report monthly scientific exchange activity according to company policy and requirements
- Ensure adherence to budget and operational accountability for assigned functions
- Ensure compliance of Medical Affairs activities
- Review promotional and educational materials for medical and scientific accuracy as requested
Management Responsibilities
- Provide leadership through effective objective setting, delegation, communication, and role modeling.
- Conduct performance appraisals as assigned. Provide measureable feedback to managed staff and outlines actions for improved performance. Formulate and implement employee corrective actions as needed.
Additional Responsibilities
- Maintain and continually expand current knowledge base and awareness of the published literature across hematology/coag therapeutic focus areas
- Attend scientific/medical/professional meetings for educational purposes and provide scientific support as required
- Assist in obtaining regional medical/scientific marketplace intelligence
- Maintain accurate, up-to-date referenced responses for most commonly asked medical scientific questions
- Maintain and expand the internal literature library and information resources
- Strong time management, organizational, administrative and computer skills
- Ability to maintain high level of ethical and compliancy standards
- Actively listens to others and is adept at confidently stating expert opinion while respecting the position of others. Exert diplomacy while standing firm on a position.
- Convert complex scientific information into lay terms and effectively communicate such information
Education and Experience
- Advanced degree in the medical/pharmaceutical sciences (PharmD)
- 8+ years related industry experience
- Ability to interpret and present complex medical topics
- Strong understanding of industry compliance guidelines
- Exceptional interpersonal skills in developing key opinion leader relationships
- Demonstrated competency in providing answers to medical and product information requests
- Understanding of drug surveillance, product promotion, and the legal aspects of product information
- Ability to critically evaluate clinical literature
Additional Requirements
- Willingness to fully engage with high energy team in pursuit of organizational goals and strategies
- Willingness to thrive within a transparent work environment
- Ability to maintain confidential information with high regard for integrity
- Excellent oral and written communication skills while continually demonstrating high levels of interpersonal versatility within diverse populations
- Strong analytical and critical thinking skills
- Ability to build relationships and establish credibility appropriately
- Self reliant and results oriented
- Ability to effectively interact with and support all levels of management
- Ability to prioritize and successfully execute multiple tasks simultaneously
- Ability to receive candid feedback and quickly make appropriate changes to improve performance
For more information contact:
Email MichelleL@ScientificSearch.com
856-761-0900, x101
Quality Assurance Manager-Philadelphia, PA
Medical Device manufacturer of Class 1 and 2 devices, located in North East Philadelphia has an immediate need for a Quality Assurance Manager.
The position reports to the General Manager and has one direct report.
Responsibilities
- Overall responsibility for QA and QC.
- Ensuring that processes are compliant with FDA QSR
- Validation of Equipment and, where needed, Process Validation
- Complaint Management, Root Cause Analysis and CAPA
- Ensuring that the product development process follows Design Control requirements per FDA QSR.
- Writing Protocols, Standard Operating Procedures and Work Instructions
- Calibration and Equipment Maintenance
- Identifying, implementing, and monitoring Quality Improvement projects
- Responsible for documenting Training and identifying training needs
- Manage Audits with both customers and regulatory agencies
- Managing Inspection (Receiving, In-Process Final)
Requirements
- BA/BS in a relevant area
- General knowledge of FDA QSR or ISO 13485
- 3-5 years experience in a relevant role in an FDA regulated Manufacturing environment with CGMP
- Documented experience in Equipment and Process Validation
- Blueprint reading
- Basic knowledge in Statistical Analysis
- Good written and verbal communication skills.
For immediate consideration, email resume to tom@scientificsearch.com
Job Summary:
We are currently seeking a Director, Pharmacovigilance for our client’s Northern New Jersey location. This position will provide oversight of the case processing function, including the management of workload, staff, and associated processes, and ensuring quality and compliance of the team’s deliverables.
Responsibilities:
In this role, you will assess and manage workload and resources on an ongoing basis to maintain quality and high regulatory compliance. Evaluate metrics reports and regularly provide updates to management. Implement processes to ensure accountability at every level within case processing.
- Assess department processes; draft and review case processing SOPs and SOIs.
- Oversee DSPD’s role in supporting global aggregate reports (e.g., PSUR and DSUR) and requests from license partners.
- Participate in global committees to establish standards in safety operations across different RM sites.
- Provide RM support to project teams when needed, including oversight of quality of SAE processing work performed by CROs.
- Review study protocol/safety section and assess impact on safety processing workload.
- Provide support for company initiatives in establishing standards for study protocol template/safety section, SAE reconciliation, and CRF standards..
Job Requirements
- Minimum: Bachelor degree in nursing or pharmacy or health-related field (advance degree preferred);
- Minimum: Seven years of pharmacovigilance experience, including experience in a management role.
- Strong sense of ownership and commitment to excellence;
- Excellent organizational skills;
- Excellent written and verbal communication skills;
- Ability to work in a team environment;
- Strong people management skills;
- Efficient in time management and multi-tasking.
- Knowledge of FDA regulations, ICH guidelines and GCP;
- Knowledge of safety database;
- Understanding of how pharmacovigilance impacts other aspects of Risk Management.
For immediate consideration please email resume to Lisa Gabor, LisaG@scientificsearch.com
