Job as CDM and Medical Writing associates [3 Posts] : Raaj Global Pharma Regulatory - Fresher or 1-2 yrs experienced Affairs Consultants

Raaj GPRAC is Thane Mumbai based Pharma Consultants and Trainers. We are cGMP, GLP Auditors and Trainers and provided services to more than 100 clients from different areas like Pharma, Biotech, BPO, KPO, CRO and Neutraceuticals, Herbals, Food industry,. We have trained more than 3500 candidates till date.
We offer various job related courses in Regulatory Affairs, QA-QM, CTD/eCTD submissions, Clinical research, Patents, Pharma Management, Pharma Documentation, PharmacoVigilanace, Medical Writing and Global Regulatory Affairs. We provide 100% job assistance.

Post: CDM and Medical Writing associates [ 3 Posts]

Job Description:
1) Provide Clinical data management support to team and/or study project, Clinical Data Management team and Biostatistics team.
2) Participates in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).
3) Develops Data Management Plan (DMP), maintains DMP throughout lifecycle of study project and ensures DMP is followed according to study design and requirements.
4) Develop Case Report Form (CRF), electronic and/or paper.
5) Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
6) Develops Data Transfer Agreement(s) (DTAs) between external data vendors and/or core labs.
7) Ensure clinical data with 100% quality check
8) Assist in defining and/or create data listings, summary table validation, data specifications and/or process data transfers in preparation for statistical review and/or data management audit.
9) Help in writing CTD modules and compiling sections as per regulatory requirements.
10) Coordinate the archiving of study databases and related documents.
11) Excellent verbal and written skills, good organizational, interpersonal, and team skills.
12) Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
13) Participate in conference calls and/or meetings with vendors.

Candidate Profile:
Bachelor’s degree in a science related field, B.Pharm /M.Pharm /M.Sc /BAMS /BHMS can apply
Fresher or 1-2 yrs experienced

Additional Information:
Qualification: B.Pharm /M.Pharm /M.Sc /BAMS /BHMS
Experience: 0-2 Years
Location: ANY
Industry Type: CRO
Functional Area: CR