- Title: Medical Information Specialist
- Code: RCI-03093
- Location: Bridgewater New Jersey (NJ) 08807
- Posted Date: 10/15/2020
- Duration: 6 Months
- Name:Ankit Shah
- Email: Ankit.Shah@rangam.com
- Phone: 908-704-8843 ✖ 210
Responsible to manage and maintain accurate response documents for Consumer Healthcare (CHC) products. Respond to escalations and interact with our contact center Team. Collaborate with Medical, Regulatory, R&D, and Quality colleagues within to ensure appropriate responses using a state of art tracking and repository system. Additional activities include assisting in review of medical compendia and contributing to our NDA annual reports. Exceptional organizational skills and customer centric service required.
At least 1 year performing Medical Information related writing scientific response documents, responding to medical and non-medical related consumer healthcare product escalations.
Knowledge of basic medical information requirements and compliance procedures and ability to understand consumers point of view.
Ability to organize and collaborate with Medical, Regulatory, Quality colleagues a must
- The role is primarily responsible for managing the OTC products response documents & escalated medical information and related inquiries.
- Ensure the quality and integrity of SRDs used to provide responses to patients & healthcare professionals on OTC and OTC to Rx products.
- Entering inquiries into a Sales Force based CRM and maintaining SRDs in Veeva Vault.
- Localizing global scientific response documents (GSRDs) with local content, as needed for Established products and responding to escalated global and local inquiries.
- Provide review of select medical compendia for selected Rx products.
- Provide summaries of literature searches for NDA product annual reports.
- Editing and writing proficiency.
- Perform literature research and critically evaluate scientific data.
- Contribute to departmental efforts to support medical information activities.
- Work cross-functionally with Medical, Regulatory, Quality and Customer Service team members.
- Organizational skills. Ability to identify and understand issues, problems and opportunities using effective approaches for choosing a course of action or developing appropriate solutions.
- Knowledge of products, product labeling, and Federal Regulations pertaining to OTC and pharmaceutical products a plus.
- Excellent written and oral communication skills including a good understanding of Medical Writing.
- Knowledge of Word
- Knowledge of Sales Force CRM a plus (not required).
- Ability to work in a cross-functional team. Uses appropriate interpersonal styles and communication methods to work effectively with business partners to set and meet mutual goals and objectives; builds networks to obtain cooperation without relying on authority.
- PharmD preferred
- 1 year experience in Medical Information preferred