MedTech Technical Writer
Company Name:-
IQVIA
Job Location:-
Bengaluru, Karnataka
Job Summary:-
Job Overview
Acts as a Lead Medical Writer on straightforward projects (e.
g.
simpler documents under standard timelines).
Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines.
Negotiates timelines and discusses/resolves customer comments, with senior support as needed.
Keeps abreast of current medical and/or technical writing/regulatory knowledge, including GCP, along with developments and advances in device development/medical and/or technical writing.
Essential FunctionsTake a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.
Manage day-to-day workload: identify project needs, track timelines and implement customer requests, keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.
Attend project team meetings with or without other writers.
Participate in/lead comments resolution or similar meetings with external customers.
May give simple presentation to an existing customer (e.
g.
on processes at a Kick-off meeting).
Complete project finance activities, including monitoring and forecasting budgeted hours.
Awareness of budgets and project finance principles, moving towards review and understanding of budgets relating to assigned projects, including out of scope activities.
QualificationsBachelor’s Degree Bachelor’s Degree in life sciences related discipline or related field ReqMaster’s Degree Master’s Degree in life sciences related discipline or related field PrefPh.
D.
Ph.
D.
in life sciences related discipline or related field PrefTypically requires 1-3 years of prior relevant experience and related competency levels.
ReqFamiliarity with the structural and content requirements of clinical investigation plans, clinical study reports and similar documents.
ReqGood understanding of common statistical methods used in clinical trials and/or interpretation of their results.
ReqAbility to effectively review a statistical analysis plan and to identify deficiencies, erro
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