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Medical Writer Jobs in Chandigarh,Delhi,Faridabad - Turacoz Healthcare Solutions

Medical Writer

Turacoz Healthcare Solutions
Expired

Posted: 23 Nov 17

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
General Knowledge and Skills
  • 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

Role others
Who can apply Freshers
Hiring Process Written-test, Face to Face Interview
Employment TypeFull Time
Job Id361250
Locality Address
Country India

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.

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