Princeton
NJ
Qualifications/Requirements: - MD degree
- Minimum 3 years of pharmaceutical and/or biotechnology industry experience in Pharmacovigilance or Drug Safety
- Completed a medical residency and possess clinical/patient care work experience before moving into PV/pharma industry
- Strong post-marketing and investigational event and aggregate assessment/review/documentation skills.
- Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines.
- Experience in communicating with the FDA, EMA , and other global health authorities.
- Experience in developing case series retrieval strategies.
- Working knowledge of MedDRA coding
- Available for domestic and international travel
- Must be legally authorized to work in the United States
- Must be willing to work in our Princeton, NJ facility
- Must be willing to submit to a drug test and background check
- Must submit application for employment through gecareers.com to be considered
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics: - Knowledge of other languages desirable. - Collaborative internal relations with Regulatory Affairs, Medical Affairs, Quality and Legal Counsel, with a mindset to share information regarding potential or confirmed safety issues as soon as safety information allows - High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a ?player/coach? as necessary, and an appetite to lead all activities within the medical affairs and clinical development functions - Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills - Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances - External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment - Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others - Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely - Demonstrated success in building effective teams, systems, and processes; proven ability to identify, select and manage a variety of external resources. - Ability to lead a team of functional experts and negotiate the multi-disciplinary environment in which they operate - Understanding of pharmacovigilance -related information systems. - Experience in working with epidemiologists to develop and implement strategies that lead to an understanding of a product-event relationship. - For PV Physicians serving as the EU-QPPV and Deputy QPPV, an excellent working understanding of the roles and responsibilities of the QPPV as outlined in Volume 9A of the European Union. - Oversight of the pharmacovigilance and risk management strategy regarding products under increased regulatory scrutiny, with responsibility for the medical safety content of all documents required to implement and monitor the progress of risk management plans and for responses to ad hoc safety issues to regulatory authorities.
Posted On -
6/18/2013 6:09:55 AM
Princeton
NJ
Qualifications/Requirements:
* MD degree
* Minimum 3 years of pharmaceutical and/or biotechnology industry experience in Pharmacovigilance functioning as a Pharmacovigilance Physician
* Successful completion of medical residency and possess clinical/patient care work experience before moving into PV/pharma industry
* Minimum 6 years of experience in both clinical trials and postmarketing pharmacovigilance
* Minimum 6 years of experience in signal detection and evaluation.
* Strong post-marketing and investigational event and aggregate assessment/review/documentation skills.
* Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines.
* Strong experience in risk management plan preparation and review, including European Union Risk Management Plans (EU ? RMPs) and US Risk Evaluation and Mitigation Strategies (REMS).
* Experience in communicating with the FDA, EMA , and other global health authorities.
* Experience in developing case series retrieval strategies.
* Working knowledge of MedDRA coding
* Available for domestic and international travel
* Must be legally authorized to work in the United States
* Must be willing to work in our Princeton, NJ facility
* Must be willing to submit to a drug test and background check
* Must submit application for employment through gecareers.com to be considered
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics:
* Knowledge of other languages desirable.
* Collaborative internal relations with Regulatory Affairs, Medical Affairs, Quality and Legal Counsel, with a mindset to share information regarding potential or confirmed safety issues as soon as safety information allows
* High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a ?player/coach? as necessary, and an appetite to lead all activities within the medical affairs and clinical development functions
* Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills
* Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances
* External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment
* Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
* Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely
* Demonstrated success in building effective teams, systems, and processes; proven ability to identify, select and manage a variety of external resources.
* Ability to lead a team of functional experts and negotiate the multi-disciplinary environment in which they operate
* Understanding of pharmacovigilance -related information systems.
* Experience in working with epidemiologists to develop and implement strategies that lead to an understanding of a product-event relationship.
* For PV Physicians serving as the EU-QPPV and Deputy QPPV, an excellent working understanding of the roles and responsibilities of the QPPV as outlined in Volume 9A of the European Union.
* Oversight of the pharmacovigilance and risk management strategy regarding products under increased regulatory scrutiny, with responsibility for the medical safety content of all documents required to implement and monitor the progress of risk management plans and for responses to ad hoc safety issues to regulatory authorities.
* Expert in Aggregate Report preparation and review.
Posted On -
6/18/2013 6:09:55 AM
Piscataway
NJ
Qualifications/Requirements: Bachelor?s degree in Engineering
- 5 or more years of Service experience
- 5 or more years of Leadership experience
- Proven experience leading a team, managing customer relationships and/or managing a P&L or comparable business unit
- Ability to develop and execute multiple priorities and approaches to meet objectives
- Exceptional interpersonal skills
- Willingness to travel 25% within your specified geographic region
- Proven team builder and leader
- Strong financial acumen
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics: -MBA - Demonstrated verbal and written communication skills - Prior field sales or field service experience - Prior experience with distributed workforce
Posted On -
6/17/2013 6:28:33 AM
Princeton
NJ
Qualifications/Requirements: 1. Bachelor?s degree in a Scientific field
2. Minimum 5 years Quality Assurance/Regulatory Assurance experience in the pharmaceutical industry
3. Minimum 5 years experience in a GCP and GLP environment
4. Prior experience using word processing, spreadsheet, and presentation software
5. Demonstrated experience with regulations in the medical device and/or pharmaceutical industries
Also,
- Must be legally authorized to work in the United States
- Must be willing to work in our Princeton, NJ facility
- Must be willing to submit to a drug test and background check
- Must submit application for employment through gecareers.com to be considered
- Must be willing to travel at least 30% of the time (based on the need of the position)
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics: 1. Proven managerial/leadership skills such as work planning, delegating & evaluating (if Site Mgr has direct reports)
2. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes
3. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and research and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
4. Demonstrated collaboration, negotiation & conflict resolution skills
5. Excellent oral communication & report, business correspondence & procedure-writing skills
6. Proven mentoring and coaching abilities, demonstrated ability to motivate & inspire others
7. Proven leadership skills (experience successfully managing people/projects/issues)
8. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance
9. Change agent with energy, passion & enthusiasm to drive change
10. Demonstrated effective interpersonal, teamwork & networking skills
11. Exceptional analytical, problem solving & root-cause analysis skills
12. Ability to make decisions, even when under pressure & take ownership for assigned projects and programs
13. Ability to multi-task & handle tasks with competing priorities effectively
14. Integrity: Accepting & adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others
15. External Focus: Understanding customer needs, marketplace dynamics, industry trends, & the competitive landscape in the industry/function & considering the external impact of business activities & decisions on the external environment
16. Inclusiveness: Energizing others by building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others
17. Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly & concisely
Posted On -
6/6/2013 7:30:29 AM
NA
CA
Qualifications/Requirements:
- Life Sciences education and work experience.
- 2 ? 5 years? experience selling life science equipment and/or consumables.
- Selling skills.
- Negotiating skills.
- Communication skills.
- Interpersonal skills.
- Fluent English.
- Knowledge of market place.
- Appreciation of business environment.
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics:
- Team working skills (incl. Ability to harness resources to achieve goal).
- Presentation skills.
Posted On -
6/5/2013 6:45:43 AM
NA
CA
Qualifications/Requirements:
- Bachelor's Degree
- Minimum of 7 years of consultative sales experience.
- Minimum of 2 years of experience managing sales professionals in a regulated environment
- Excellent communication skills. Strong computer skills, with demonstrated capabilities utilizing the Microsoft OfficeTM suite of products
- Willingness and ability to frequently travel within the specified geographic zone, as well as occasional travel outside the Zone
- Basic forecasting skills and an understanding of fundamental financial principals
- Ability to safely operate a GE owned/leased or rental vehicle for company business (you must be willing to submit to a check of your driving record).
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics:
- Experience in a commercial organization serving the BioProcess segments
- Masters degree in Business or Life Sciences
- Range of technical knowledge across BioProcess applications (e.g. Cell Culture, Filtration, Chromatography, etc.)
- Prior experience working for a large company in a matrix organization
- Knowledge of project management techniques and experience selling capital equipment and long-sales cycle products and services.
Posted On -
5/31/2013 6:23:23 AM
NA
CA
Qualifications/Requirements:
- Medical Degree with specialization in Oncology with at least 5 years? experience in clinical practice.
- Ability to work within a matrix environment and to interact with multiple stakeholders as well as external MDs.
- Must be willing to relocate and work out of San Ramon, CA or Aliso Viejo, CA
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics:
- Experience in translational medicine and in conduct of clinical trials.
- Ability to effectively communicate on complex medical issues such that non-medics are able to grasp the key points.
- Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations.
- Clear thinking: Simplifying projects into specific actions, making quick and accurate decisions based on available information, and communicating priorities clearly.
- External focus: Understanding customer needs, trends in clinical practice, and the ability to anticipate the future impact of new science.
- Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
Posted On -
5/22/2013 6:00:36 AM
Princeton
NJ
Qualifications/Requirements:
* Bachelor's degree in Nursing or PharmD
* Minimum 5 years of pharmaceutical and/or biotechnology industry experience in Pharmacovigilance.
* Basic understanding of data mining in the evaluation of safety signals
* Strong post-marketing and investigational event and aggregate assessment/review/documentation skills.
* Strong working knowledge of US/EU/AP/LA regulations and ICH guidelines.
* Experience in developing case series retrieval strategies.
* Strong knowledge of MedDRA coding.
* Available for domestic and international travel
* Must be legally authorized to work in the United States
* Must be willing to work in Princeton, NJ facility
* Must submit application for employment through gecareers.com (or COS if internal) to be considered
* Must be 18 years of age or older
* Must be willing to take a drug test as part of the selection process
* Must be willing to submit to a background investigation, including for example, verification of your past employment, criminal
history, and educational background
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics:
* Knowledge of other languages desirable.
* Ability to work collaboratively with PV Physicians in all pharmacovigilance-related activities.
* High integrity, sense of urgency, ability to recognize time sensitivity, willingness to work in a matrix environment and assume the role of "player/coach" as necessary
* Excellent written and verbal communication skills, exceptional listening skills, strong presentation skills, and good negotiating and influencing skills li>Experience in working with epidemiologists to develop and implement strategies that lead to an understanding of a product-event relationship desirable.
* Prior experience in pharmacovigilance and risk management strategies regarding products under increased regulatory scrutiny and in assisting PV Physicians in providing the medical safety content of all documents required to implement and monitor the progress of risk management plans and responses to ad hoc safety issues to regulatory authorities.
* Advanced knowledge and understanding of safety database search strategies to support the Pharmacovigilance Physician in the identification and evaluation of safety signals.
- Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances
- External Focus: Understanding customer needs, marketplace dynamics, industry trends, and the competitive landscape in the industry/function and considering the external impact of business activities and decisions on the external environment
- Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
- Clear thinker: Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely
* Basic understanding of pharmacovigilance -related information systems other than safety databases, such as health claims databases for the identification of safety signals using data mining techniques.
Posted On -
5/14/2013 6:13:55 AM
Princeton
NJ
Qualifications/Requirements: - Bachelor?s Degree
- Minimum 5 years regulatory affairs experience in the pharmaceutical industry
- Minimum 1 year post-marketing regulatory affairs experience
- Minimum 2 years experience reporting/negotiating to FDA and EU health authorities
- Prior experience using spreadsheet and presentation software
-Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
-Must be willing to work in our Princeton, NJ facility
-Must be willing to submit to a drug test and background check
-Must submit application for employment through gecareers.com to be considered
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics: - Regulatory Affairs Certification (RAPS). - Knowledge of Quality Management Systems (QMS) - Ability to work across cultures/countries/sites - Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. - Strong problem solving, negotiation and influencing skills - Ability to work well independently & in a team setting to provide timely, constructive and authoritative regulatory opinion and advice on all regulatory aspects. - Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies. - Ability to prioritize, plan & evaluate deliverables to established strategic goals. - Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment - Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research. - Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner
Posted On -
5/8/2013 6:30:05 AM
NA
PA
Qualifications/Requirements:
- Bachelor Degree in Science or Engineering.
- 3 to 5 years working in bioprocessing e.g., bioprocess engineering, bioprocess project management, bioprocess line management, downstream purification lead.
- 1 to 2 years in sales.
- Good overview knowledge of upstream and downstream processes.
- Sales expertise in downstream is a highly desired.
- Ability to interface with both internal and external team members as part of solutions based sales approach.
- Ability to develop and build rapport at all levels within an organization.
- Strong team player.
- Excellent verbal and written communication skills in English.
- Strong presentation skills with ability to synthesize and explain complex issues.
- Valid motor vehicle license
- Location: Philadelphia area, easy access to King of Prussia.
Additional Eligibility Qualifications: GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Desired Characteristics:
Posted On -
4/29/2013 6:21:15 AM
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