2018-03-30

Director, Medical Information
Job Opportunity at Clinical Dynamix, Inc.

Posted on Mar 30

http://www.clinicaldynamix.com    888-558-2546

Location: Waltham, MA
Job Type: Full Time
Job ID: W4156447

Leading Pharmaceutical Company with marketed products and strong Neurology Pipeline is looking for a
Director, Medical Information
for their growing US Headquarters in Waltham, MA
Competitive Base, Bonus, Long Term Incentives and Relocation
The Director, Medical Information (MI) will be responsible for leading the MI function within the Medical Affairs. The Director, Medical Information will be responsible for managing the member of the MI function who are providing and supporting the provision of accurate, scientifically balanced and timely responses to inquiries received from health care professionals, consumers and other customers.  He/She will monitor the scientific literature and communicate new data to relevant internal groups as well as work cross-functionally in support of Medical Affairs.   The Director, Medical InformationI will assist in the development of core disease state curriculum and contribute to providing disease state and product training to internal and external stakeholders.  Candidates applying for this position must have the ability to take initiative and work independently requiring minimal supervision. The Director, Medical Information will report directly to the Head of Medical Affairs Operations.
Responsibilities:
 
 
  • Manage day to day operations for the medical information call center
  • Provide guidance and supervision to the medical information call center pharmacists and nurses
  • Provide guidance and supervision to the medical information staff at Company headquarters
  • Ensure accurate, balanced and timely medical and scientific information is provided compliantly to internal and external customers (such as health care professionals, consumers and other customers)
  • Receive, identify, document and triage adverse events and product complaints to ensure compliance with health authority regulations and internal procedures
  • Apply knowledge of business strategy and inquiry activity to identify business needs, trends and emerging issues, raising awareness with appropriate Company colleagues.
  • Contribute to departmental/organization efforts to support new product launch preparation and activities
  • Independently research and write medical response documents (Standard Response Letters, Medicaid Submission Documents, AMCP Dossier, etc.), create unique responses and proactively update existing response documents on an ongoing basis; obtain approval for use to ensure compliance with existing regulations, policies and procedures; train others (call center, medical affairs, medical science directors) on their content and use either by directly doing or by supervising those doing the work
  • Perform quality monitoring of inquiry handling, ensure identification and reporting of potential adverse events and product complaints and are triaged accordingly to PV and QA
  • Proactively monitor the literature for new scientific information; identify relevant publications, analyze and communicate information of interest internally in an accurate, balanced and timely manner
  • Create and/or review for accuracy, communications containing medical and scientific content intended for internal and external customers (e.g., communications Q&A material, dear health care provider letters, documents for public comment, ect.) either by directly doing or by supervising those doing the work
  • Develop and/or identify content for the development of disease and product training material for sales associates and others as needed; provide live training upon request
  • Work with internal and external legal counsel to ensure compliance with company policies and procedures
  • Provide medical and scientific input and contribute to assigned product and project teams
  • Collaborate closely with members of other internal groups (e.g., Regulatory, Marketing, Sales, Legal, Clinical R&D) as needed
  • Contribute to the review of internal promotional and medical materials either by directly doing or by supervising those doing the work
  • Provide information and support for business activities such as relevant insights, knowledge of product data, etc.
  • Attend scientific conferences to provide medical support and to staff medical information booth as assigned
  • Lead pre-conference Medical Affairs/Medical Information activities
  • Develop post-conference reviews and reports for internal stakeholders
  • Domestic and International travel will be required (30%)
 
Education and Experience:
Advanced scientific degree preferred (PharmD, PhD)  
Knowledge or Skills Needed:
  • Advanced scientific degree with 5-7 years of medical information within the pharmaceutical industry required
  • Experience in people management required
  • Experience in medical information, medical affairs, and/or clinical development preferred
  • Ability to work in a fast paced environment with competing priorities
  • Ability to read, interpret, and convey complex scientific information
  • Ability to work independently with minimal supervision
  • Excellent written and verbal communication skills
  • Excellent customer service skills
  • Exceptional interpersonal skills
  • Experience working in a team environment and the ability to work collaboratively towards a common goal
  • Knowledge of pharmaceutical industry regulations, guidelines, standards and practices
  • Demonstrated results orientation and problem solving skills
 

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