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Covance - Medical Writer (2-4 yrs) Premium

Mumbai Job Code: 11684

About the Company :


Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our nearly 65,000 enterprise team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you- ll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.


Job Overview :

- Independently prepare lower complexity protocols and CSRs including interpretation of clinical data and statistical results as appropriate

- Work with more experienced colleagues in the development of higher complexity protocols and CSRs, and other clinical documents as needed

- Independently prepare and review patient safety narratives

- Provide support and project management of narrative projects

- Prepare and/or oversee compilation of CSR appendices

- Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines

- Independently review Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) for assigned studies to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.

- Incorporate internal and/or external review comments on clinical documentation

- Communicate with internal/external clients as needed to facilitate achievement of project goals

- Participate in meetings with internal and external clients, with guidance and support from colleagues. Lead meetings as appropriate

- Responsible for project coordination and adherence to project timelines and budget, as appropriate

- Represent department in inter-department working groups

- Provide training and guidance to Associate Medical Writers and other staff as appropriate

- Comply with Covance internal processes and procedures

- Performs other duties as assigned by Management

Education/Qualifications:

Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred

Experience:

Minimum Required:

- Typically minimum 1 years medical writing experience or 2 years professionally-related experience

- Excellent command of written and spoken English

- Good written and verbal communication skills

- In-depth knowledge of MS Word

- Good organizational and time management ability

- Excellent interpersonal skills

- Scientific or Clinical research experience desirable

- Good scientific writing skills.


- Understanding of medical, pharmacokinetic and statistical principles

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