Medical Writer Jobs in Chandigarh,Delhi,Faridabad - Turacoz Healthcare Solutions
Job Description
Below are the skills a medical writer is expected to have to work in a medical communications agency:
Domain Knowledge
- Medical and Therapeutic Area
Knowledge:
Knowledge of medical terminologies and concepts, technical knowledge of
therapeutic areas viz. cardiology, rheumatology, oncology, neurology
etc.,
- Drug Development Process,
Pharmacology, and Drug Safety: A basic understanding of
clinical research including drug development process, regulatory
documents such as protocols, investigator brochures, clinical study
reports and related guidelines. In addition, a knowledge of the
pharmacology, pharmacokinetics, and safety of drugs
- Statistics: basic understanding of
statistics to be able to understand confidence intervals, regression
analyses, randomization schemes, P values, and t-tests.
- Technical Guidelines: ICH-GCP guidelines, ICMJE
guidelines, and GPP guidelines
- Language and Grammar: basic scientific aspects,
clear presentation of concepts as per the target audience, use of
grammatical correct language, simple and short sentences in active voice,
maintenance of logical flow of the document
- Literature and Reference
Searching:
knowledge of search engines such as Medline, EMBASE, PubMed.
Understanding of the importance of referencing, and referencing styles
- Interpretation and
Presentation of Data:
writing scientific documents involves review and interpretation of
research data, presentation of those data in text, tables, and graphs,
and developing logical discussion and conclusions as to what the data
means.
- Required Qualification:B.
Pharm, M. Pharm, D. Pharm, Ph.D., MBA
Job Particulars
About Company
Turacoz provides regulatory support for pharma and healthcare sector in following ways:
- Regulatory Affairs and Consultancy: Consultancy in development and planning, submissions like IND, NDA, MAA, CTA, IMPD, IMDD, and labelling
- Clinical Research and Regulatory Writing: Documents preparation like protocols; informed consent forms (ICFs); case report forms (CRFs); clinical study reports (CSR); investigator’s brochure (IB); clinical overview (CO), non-clinical overview (NCO), clinical summary, and non-clinical summary of common technical document (CTD); clinical trial disclosures etc.
We take complete responsibility for on time and successful submissions. Our core strengths include both pre- and post-approval submission documents. We also expertise in specific quality check (QC) and quality assurance (QA) projects. We have thorough knowledge of various regulatory guidelines like that of United States Food and Drug Administration (US FDA); European Medicines Agency (EMA); Japanese Ministry of Health, Labour and Welfare (MHLW) and Japanese Pharmaceuticals and Medical Devices Agency (PMDA); The Federal Institute for Drugs and Medical Devices (BfArM); Central Drugs Standard Control Organization (CDSCO) and Drug Controller General of India (DCGI); and Rest of the World (ROW). Moreover, our service spectrum covers all kind of products ranging from drugs and generics to biologics and biosimilars, diagnostics and medical devices, immunologics etc. We thoroughly follow ICH-GCP guidelines and templates to create quality and regulatory compliant documents.