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Carry out independent site feasibility and selections
Help with site initiation and trial activation
Carry out independent site monitoring; online and offline
Help with preparing Serious Adverse Event report filing with the regulatory
Provide assitance to site in protocol related queries, ICH GCP Training for site personnel
Be a liasion between the sponsor, investigator and CRO
Support the site prepare and face regulatory audit / site inspections
Medical content writer
Salary: 5-9 LPA
About ZenOnco.io:
https://zenonco.io/">ZenOnco.io is the world’s first integrative oncology healthtech platform. At ZenOnco.io, we aim to extend life and improve the quality of life for cancer patients through integrative oncology treatment, which covers both medical treatment as well as complementary treatment (Nutrition, emotional wellness, fitness, and community support).
To provide the best medical treatment options to cancer patients, we have partnered with 50+ hospitals across India, and cover 1,000+ oncologists. We also provide patients access to a full range of diagnostic tests that are required to arrive at the most effective cancer treatment.
We heavily deploy technology in our operations, and have recently launched the world’s first Integrative Oncology Preliminary Assessment Report tool (ZIOPAR) to guide cancer patients free of cost on the possible treatment options based on their cancer profile, symptoms and other conditions.
We believe in innovation, dedication and commitment. While we have the thrill to seek out and capture the world, we are looking for a responsible partner in you. If you feel you can become one of us, apply today.
Company introduction video: https://bit.ly/ZenOncoIOintroduction">https://bit.ly/ZenOncoIOintroduction
Role and responsibility:
Acts as Lead Medical Writer and performs competently on straightforward projects, with guidance from senior staff as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with Quintiles SOPs and the customer’s requirements. Identifies project needs, tracks project timelines and implements client requests with senior review.
- Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed.
- Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery.
- May perform QC review of documents or parts of documents prepared by more senior staff.
- Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff.
- Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing.
- Complies with Company SOPs and participates in the implementation of new SOPs.
Required knowledge, skills, and abilities:
Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally.
- Familiarity with the structural and content requirements of clinical study reports, protocols, and similar documents.
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
- Competence in completing a good first draft clinical study report in a routine therapeutic area within a reasonable timeframe with limited guidance.
- Good understanding of common statistical methods used in clinical trials and interpretation of their results.
- Ability to give a simple presentation to a project team and/or customer, e.g. on Medical Writing processes.
- Ability to identify inconsistencies and deficiencies in statistical output.
- Coordinate with various technical professionals to gather, organize and compile information on new products or processes
- Go through medical topics and assist physicians in writing research related articles and reviews
- Assist in preparing press releases, training material and marketing content
- Write articles and reports on research discoveries connected to health and medical fields
- Communicate complex medical information in a succinct way
- Work with clinical researchers in the development of research protocols
- Participate in the preparation of various clinical research and regulatory documents
- Prepare annual reports, brochures, abstracts and presentations
- Prepare training materials and eLearning content according to the needs of the audience
- Make sure all applicable guidelines and regulations are followed
- Stay up to date on current industry practices and regulations
- Knowledge of regulations relevant to medical writing
Education and Experience:
Bachelor’s or Master’s degree in a life science-related discipline, plus at least 4 years+ experience as a medical writer within a pharmaceutical environment; or equivalent combination of education, training and experience.
You will get:
- Some of the best people to work with (founders are IIM graduates and investment banker)
- An opportunity to make a difference in the lives of millions of cancer patients across the globe
- A great learning environment and opportunity to grow
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