Protocol / Medical Writer - Late Phase - Brillex Clinical Research Brillex Clinical Research Pvt. Ltd.

1.0 - 4.0 years

4 - 6 Lacs

gandhinagar, ahmedabad

Work from Office

Role & responsibilities 1. Responsible for clinical trial medical science related activities like preparation of protocol, Informed consent form, CRF, other study related documents and SOPs in line with ICH GCP, Indian and global regulatory. 2. Conduct relevant literature search for required for protocol and manuscript writing. 3. Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines. 4. Ensure to follow all clinical and regulatory guidelines, processes and systems for medical science activities and ensure compliance to internal medical writing SOPs for Clinical trial. 5. Compiles, writes and edits medica...

Posted 1 month ago

AI Match Score

Apply

APM/PM - Late Phase - Brillex Clinical Research Brillex Clinical Research Pvt. Ltd.

7.0 - 12.0 years

10 - 15 Lacs

gandhinagar, ahmedabad

Work from Office

Role & responsibilities Develop and manage comprehensive project plans, including timelines, budgets, resource allocation, and risk mitigation strategies. Oversee all aspects of trial startup, including site selection, contract negotiation, IEC/IRB submissions, and study team training. Monitor trial progress against established milestones and timelines, proactively identifying and addressing potential delays or roadblocks. Manage project budgets, track expenses, and ensure cost-effectiveness. Collaborate with cross-functional teams (e.g., medical, biostatistics, data management, regulatory) to ensure seamless project execution. Manage vendor relationships, including selection, contract negot...

Posted 1 month ago

AI Match Score

Apply

Business Development - Late Phase CRO CIEL HR

10.0 - 17.0 years

25 - 40 Lacs

Ahmedabad

Work from Office

Role & responsibilities Drive business development for late-phase and RWE services in assigned global territories (US/EU/APAC). Identify, engage, and convert new clients (pharma, biotech, medical device companies) seeking post-marketing and observational study solutions. Lead end-to-end proposal development, including scope definition, pricing strategy, and bid defense presentations. Partner with Lambdas scientific, medical, and operational teams to ensure feasibility and alignment of proposals with delivery capabilities. Maintain in-depth understanding of industry trends, regulatory frameworks (e.g., EMA, FDA post-marketing requirements), and client needs in the RWE and late-phase space. Re...

Posted 3 months ago

AI Match Score

Apply

General Manager - Bio Statistician NA

10.0 - 20.0 years

45 - 70 Lacs

Ahmedabad

Work from Office

Desired Experience Experience of biostatistics in regulated markets Interacted with regulatory agencies (FDA/EMA/PMDA) Experience of biosimilar product development Knowledge of statistical models, meta-analysis, regression, longitudinal data analysis Knowledge of using relevant software including PASS, SAS, SPSS, R Job Description Prepare scientifically sound statistical design for clinical trials Design clinical trials for biosimilars for global requirements (FDA/EMA/PMDA) Perform meta-analysis and calculate sample size Prepare statistical justifications for agency interactions (FDA/EMA/PMDA) Review and provide inputs to statistical sections of clinical trial protocol Plan and perform blind...

Posted 3 months ago

AI Match Score

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.