Question

you are a Director R&D Clinical Studies

Please answer the following questions No Plagiarism please

Try to use approximately 100 words each question

Please Type.

Please do no plagiarize. If you don't know please don't answer thanks

Plagiarism is being investigated by chegg

1 How would you say that your job relates to the drug development process?

2 What has been the most difficult part of working with clinical trials?

Answer 1

Drug developers process a job profile

The drug developers are generally known as pharmaceutical scientists. The job description of this is quite vast in nature, the main features of this are designing of specific drug projects which the company demands to start production. There are many things that needs to be kept in mind before there is development of a drug. The drug developer must collect review of literature from most sources to support his document. The drug developer plans the execution of the plan to be implemented, creation of work process, dividing the team with an intension of creating framework or strategy. Work out regulatory steps that need to be followed for the submission of the proposed drug as per the guidelines of health authority and according to guidelines of the competent authority. The next role is to offer technical support, along with tech transfer under necessary circumstances. The next profile responsibility if the drug developer is independently being responsible for the conception, design, implementation, and interpretation of scientific and technical data to support projects that need approvals as well as vice-versa. Lead scientific staff to design, implement, and interpret the data by developing work streams. as a core team member on multiple concurrent project workstreams, solves complex problems through collaborations with others, taking a new perspective on existing solutions. Maintaining relationships with technical development team with high quality partners beneficial to the organization, both internally and externally, to strengthen development/implementation of new methods/technologies.

Question 2

The most difficult part in working under clinical trials: there are many factors that have made clinical trials difficult but the most difficult one was liaising with ethics committee regarding rights, safety, and well-being of trial subjects. Liaising with regulatory authorities is one of the most important and difficult part where the authorities if not convinced can bring the whole project to stand still hence, it has to understood to work hard on this part. Ensuring compliance with SOPs and local regulations, putting up standard SOP’s for the general public that too a generalised population made it difficult