Job Title : Global Regulatory Manager Location : Princeton Pike, NJ Length : 12 months Job Description: Responsibilities Analyzes and interprets scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance’s and 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 Worldwide Safety and Surveillance.
Required: 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 Job Requirements: Job Title : Global Regulatory Manager Location : Princeton Pike, NJ Length : 12 months Job Description: Responsibilities Analyzes and interprets scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance’s and 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 Worldwide Safety and Surveillance.
Required: 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