Global Regulatory Manager
Global Regulatory Manager
Job Number: 21-13294
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Global Regulatory Manager for our client in Lawrence Township, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Analyzes and interprets scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance's and Client policies and procedures, and are used to appropriately respond to inquiries from payers and Health Authorities.
- Ability to conduct literature searches in databases such as EMBASE and Pubmed/Medline
- Extensive, proven experience and skill in writing high-quality, evidence-based scientific documents
- Responsible for but not limited to: developing, editing and managing the production of AMCP Dossiers and scientific presentations for payers; developing and/or editing responses to address specific unsolicited payer and Health Care Provider requests for health outcome information.
- Manages and prioritizes multiple projects, provides solutions to complex problems, and delivers complete and accurate information within deadlines
- Maintains awareness of current industry practices that pertain to Medical Information
- Complies with the reporting of adverse effects and product complaints to Client Worldwide Safety and Surveillance.
- Doctor of Pharmacy or equivalent
- 2-3 years relevant industry or managed care work experience; recognized expert in medical communications and medical writing
- Oncology experience preferred
- Ability to write in a clear, concise, and persuasive manner
- Strong project management skills
- Highly proficient in the use of Microsoft Word and PowerPoint
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
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.