ASSOC. DIRECTOR, MEDICAL INFORMATION - Medical Documents, Materials Approval, AE
- Product and disease state expert within MIC, providing strategic input and direction to internal colleagues.
- Reviews promotional materials as a member of the product-specific Materials Approval Process (MAP) team.
- Also reviews non-promotional tools through eMed; medical record of patient visits to MED's exam clinic or submission of examination information to Medical Clearances
- Responds to product inquiries from external and internal customers.
- A member of the Medical Product Team.
- Creates, maintains, reviews, and approves product Medical Response Documents (MRD).
- Participates in the development and maintenance of product dossiers.
- Captures potential Adverse Events (AE), and provides disease state and product training to internal groups.
- Takes initiative and works independently requiring minimal supervision.
- Demonstrates superior performance in the Medical Information role.
- Serves as a resource to other MIC colleagues, provides guidance, coaching and mentoring and acts as a role model to MIC colleagues.
- Applications of knowledge including pharmaceuticals, Medical information, clinical research, project management, coaching, mentoring, therapeutics, training, excellent verbal and written communication skills
- Be key contact for MIC to answer brand-specific questions and craft/review answers given to external customers
- Medical Reviewer for promotional and non-promotional materials (member of Materials Approval Process [MAP] and eMed)
- Respond to Medical/Scientific inquiries by searching, retrieving evaluating and summarizing the relevant information from in-house and external sources.
- Receive Medical/Scientific inquiries regarding marketed products and products being prepared for launch
- Review and Approve Medical Response Documents for assigned products
- Based on issues identified in trials, develop product Scientific Q&A documents that can be adapted at time of launch or for business critical topics
- Collaborates closely with critical Medical Unit and brand team members
- Review analyses of customer requests for feedback and input to brand strategy
- Support internal training by providing MIM and RTMI team support
- Co-ordinate input from appropriate personnel and global MI TA team to be incorporated into responses
- Create and update responses to maintain a current and accurate information resource for all internal customers.
- Work with Clinical Research teams to identify and track clinical use issues raised during trial programs that need to be addressed for launch
- Review responses with MIC Director and other Medical personnel as appropriate
- Identify and champion best practice examples in MIC
- Provide information support for commercial activities of the Brand Team (literature updates, summarized enquiry issues; competitor intelligence)
- Be a resource and provides appropriate coaching and mentoring to MIC colleagues (e.g., MRD creation, MAP interaction, MPT contributions)
- Responsible for Project management related to TA or department initiatives
- Acts as deputy to the Director
- May be granted limited supervisory responsibility within the respective team over an MIM level colleague or student/fellow/intern as part of leadership development
- PharmD, MD or healthcare-related PhD; Bachelor (BS) degree in pharmacy with significant industry based Medical Information experience also acceptable. Advanced degree or training in particular relevant therapeutic area desirable
- MEDICAL INFORMATION, Medical Response Documents, Materials Approval Process, Adverse Events, eMED,
- Fluency in Spanish is a plus
- Pharmaceutical Industry experience required
- Minimum 2-3 years in Medical Information Management (MIM) role or equivalent
- CPO Medical Department experience
- CPO Medical Department experience
- Advanced degree or training in particular relevant therapeutic area desirable
- Excellent verbal and written communication skills
- Cross-cultural perspective
- Business knowledge and commercial marketing understanding
- Ability to lead cross-functional team
FOR IMMEDIATE CONSIDERATION SEND RESUMES to email@example.com and add 'Medical Information Director
' to the subject line.
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at firstname.lastname@example.org or 844-463-6178.
Posting ID: 559419452Posted: 2020-06-03