Position : Medical Info Specialist
Location : Lawrenceville, NJ
Duration : 6 months (Possible for extension or permanency)
- Provide TA and US leadership for Mature Products in various Therapeutic Areas.
- ensure maintenance of Mature Products portfolio
- Provide strategic regulatory input and prepare content for regulatory strategic documentation, eg response to FDA information requests
- In partnership with labeling lead facilitate identification of and internal agreement on US labeling and supportive strategy for labeling issues.
- Lead coordination and preparation for FDA interactions (written, teleconference, F2F meeting).
- Build a strong and trusted relationship with the FDA project manager.
- Act as a key contributor for the preparation of responses to queries from FDA and review content.
- Drive the US FDA submission of all asset related documents such as IND/NDA annual reports.
- Work with vendor to ensure that regulatory submissions are done in a timely manner
- Solid scientific background, Ph.D., M.D., PharmD, MS or equivalent professional experience.
- 3-5 years of experience in the pharmaceutical industry.
- Understanding of scientific content and complexities.
- Solid knowledge of US regulations, laws, and guidelines. US Regulatory experience a required.
- Good interpersonal skills; willingness to leverage strengths of the team, coordinate with outsourcing partner and peers within Mature Products Strategy and in a cross¬ functional environment.
- Ability to communicate issues and risks clearly in written and verbal format to teams and management
If hired, you will enjoy the following Eclaro Benefits:
· 401k Retirement Savings Plan administered by Merrill Lynch
· TransitChek Pretax Commuter Benefits
· Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
Interested in applying? Contact Karyn Suayan, at (201) 283.9627 or you may send your updated CV to Karyn.Suayan@eclaro.com now.
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.