CONTRACT / 6-8 MONTHS COULD BE EXTENDED
Under the guidance of the CTH assist with writing of amendments and CSRs and provide feedback on the data management plan.
Be a delegate for the CTH at internal study meetings.
Report study progress and issues, lead trial level interactions with Oncology Clinical Development Operations and other relevant functions including Drug Supply Management and Novartis local organizations.
Under the guidance of the CTH, contribute to the final analysis and ...
Involvement in cross-functional, multicultural and international clinical trial teams; demonstrated capabilities in leading specific trial related activities like planning, executing, reporting and publishing activities.
Excellent communication, organization and tracking skills. Strong operational skills and demonstrated ability to meet timelines.
Proven networking skills and ability to train colleagues.
Proven ability to work both independently or in a team setting, ...
Our client, a pharmaceutical company, is seeking a Sr. Regulatory Affairs Associate till the end of the year. The pay rate is up to $74 an hour plus benefits.
The Sr. Regulatory Affairs Associate will be responsible for:
• Advise stakeholders of submission completion.
• Find information and potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward.
• Assist in the preparation of regulatory documents.
• Compile ...
Director, Medical Science, Summit NJ area
The Director of Medical Science (MS) is responsible for providing input into the Global Project Teams in planning, designing, developing, executing and interpreting clinical studies, including but not limited to those carried out in North America (NA) the global development program. The responsibilities include, but are not limited to writing or reviewing study synopsis and protocols, medical monitoring of clinical studies, input into clinical ...
Pharmacovigilance Officer is responsible for instituting and maintaining the key aspects of PV regulation in the US territory, in line with Pharmacovigilance Group processes and standards.
The role involves collecting, monitoring, submission to FDA, and documenting of adverse reactions concerning all medical products, ensuring compliance with the company’s global/local procedures, national and international regulations/guidelines.
Medical Science Director - Oncology
Require a Medical Degree (MD) with strong scientific background and medical practice experience, a fellowship or equivalent
Experience in a pharmaceutical or biotech company, especially in early stage, exploratory clinical development of drugs and biologics.
At least 5 years of work experience in performing early development clinical activities (e.g. writing protocols and executing studies, formulating clinical development strategy and plans, providing ...
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to ...
We currently have an opening for a Senior Clinical Safety associate in our Edison, New Jersey location. This person will coordinate and lead the development and implementation of integrated product pharmacovigilance and risk management strategies aimed at achieving the optimum benefit-risk for oncology compounds in development. This individual will chair the Safety Review Team meetings for Phase 2 and 3 molecules, reviewing the evolving safety profile of oncology compounds, identifying ...
Our client in Titusville, New Jersey is looking for a Project Physician.This is a long term consulting position.If interested, Please apply to this ad
Position: Project Physician
Location: Titusville, New Jersey
The Project Physician is a responsible member of a clinical team (Compound Development Team, CDT)) and reports to the CDT Leader. The PP will be dedicated to working with the team to manage the execution of a Phase 3 Efficacy and Safety Study of an anti ...
Excellent opportunity to play an important role in the development of a new therapy for the treatment of human disease, working closely with project statisticians and CRO statisticians and statistical programmers in a clinical trials environment. The statistical analyst will interpret the Statistical Analysis Plan to determine how to analyze and display clinical trials results to assess the safety and efficacy of the new therapy.
Flexible work from home policy!
Long-term contract role!
Jun 2 -
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