|Reference # : ||17-52399
||Title : ||Excellent Job Opportunity for the position of Medical Writer V (Labeling) (7003821)|
|Position Type : ||Contract|
|Experience Level : ||
||Start Date / End Date : ||05/01/2017 / 11/01/2017
| Description |
|Job Title: Medical Writer V (Labeling)|
Work Location: Bridgewater, NJ
Length of Assignment: 6 Months
Client: A Big Pharmaceutical Company
The purpose of the position is to prepare corporate, US and EU labeling (prescribing information and patient information) documents for developmental, mature and marketed products assigned to obtain company and/or agency approval. Developmental of labeling for these products is based on study results, coordination or labeling review and approval throughout the company, preparation of labeling components for submission to regulatory agencies and participation in labeling negotiations with agencies resulting in product approvals or labeling updates. The position also includes subject matter expertise in specific labeling regulations (e.g. OTC rules) and review of local labeling to assure compliance with corporate labeling.
Knowledge of European and US regulations and international regulatory environment
Knowlegdge of labeling regulations (US, EU and Global)
Experience as labeling manager
Excellent written and verbal communication skills
Demonstrated ability to solve problems and proactivity
Ability to work with multifunctional and culturally diverse teams
Organizational skills, ability to manage multiple projects at short notice.
Excellent inter-personal skills
Fluent business English.
Interested candidates can share their most updated resume at email@example.com or they can reach out to me on #973-967-3412 Ext:3412