TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
Position: Associate Manager Medical Information - I
Location: Santa Monica CA 90404
Job Type: Temporary Assignment
Job Description:
- Responds to unsolicited medical requests regarding to the products from HCPs members of the public and internal client colleagues.
- Responses are provided in a timely manner using approved standard documents up-to-date literature support and other resources
- Uses scientific and MI expertise to drive strategic initiatives and empower key stakeholders HCPs patients and other requestors with globally aligned resources that enable timely informed decisions and improved patient outcomes
- Prepares global resources in collaboration with local affiliate teams (TA specialist team).
- Prepares local resources (affiliate MI specialist team). Vendors may be used
- Identifies reports and records adverse events and product complaints in a timely manner in accordance with SOP.
- May be asked to provide medical review for promotional and/or medical materials
Responsibilities
Routine responsibilities may include the following
- Respond to unsolicited requests for medical and scientific information regarding the products and documents in the request handling system (MiQ)
- Researches and collaborates with cross functional colleagues to provide response to complex requests. TA specialist responds to complex requests from affiliate MI and internal colleagues
- Create update and participate in review and quality check of MI response documents in accordance with local laws and regulations
- MI specialist collaborates with affiliate MI and relevant internal partners who may include medical affairs development regulatory global patient safety and operations commercial to manage global response topics and content
- MI specialist prepares data on file to support response documents and complex requests
- Maintain document repository with regular/routine review of approved documents for new data from regulatory updates scientific conferences up-to-date literature searches proactive literature surveillance or newly published materials
- Understand the needs and preferences of internal and external partners and customers
- Review and provide analysis of MI databases for trends customer insights and data gaps to guide content development and prepare customer interaction reports to share with internal stakeholders
- May oversee and/or evaluate external consultant writers
- MI specialist provides process and product training to colleagues and vendors as required
- Support departmental strategic initiatives to address major activities within TA (product launches labelling updates patient engagement etc.)
- Identify report and record adverse events and product complaints in a timely manner in accordance with SOP
- Participate in MI activities and projects in line with global and regional strategic MI plans
- Works under supervision of manager or colleague
Knowledge and Skills
- Excellent written verbal and interpersonal communication skills and the ability to work well in multidisciplinary teams across geographies
- Ability to create and provide clear communication of scientific data for different audiences including members of the public
- Knowledge and understanding of the clients marketed and investigational products
- Knowledge of applicable regulatory and legal requirements for the provision of MI in the pharmaceutical environment with understanding of regional or country regulations related to the provision of MI services
- Ability to provide analysis and evaluate clinical biomedical and scientific data
- Ability to develop and maintain good working relationships with departmental and cross-functional colleagues
- Understanding of internal and external stakeholder needs and priorities
- Serve as an advocate for MI affiliate or Global MI
- Demonstrates client s core values and Leadership Commitments
- Has a strong attention to detail excellent project management and problem-solving skills and ability to think creatively
- Good organizational and work planning skills and ability to manage multiple projects in a fast-paced environment
- Awareness of digital solutions for communicating with healthcare providers and patients
- Previous experience with problem-solving and project management preferred
Education and Experience
- Pharmacy Nursing or Medical/ Life Sciences degree/advanced degree or equivalent (PharmD preferred)
- Experience in MI or working in a healthcare environment preferred.
- Experience in the pharmaceutical industry or a MI vendor preferred.
- Experience in Cell Therapy Hematology or Oncology preferred
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company ...
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
Position: Associate Manager Medical Information - I
Location: Santa Monica CA 90404
Job Type: Temporary Assignment
Job Description:
- Responds to unsolicited medical requests regarding to the products from HCPs members of the public and internal client colleagues.
- Responses are provided in a timely manner using approved standard documents up-to-date literature support and other resources
- Uses scientific and MI expertise to drive strategic initiatives and empower key stakeholders HCPs patients and other requestors with globally aligned resources that enable timely informed decisions and improved patient outcomes
- Prepares global resources in collaboration with local affiliate teams (TA specialist team).
- Prepares local resources (affiliate MI specialist team). Vendors may be used
- Identifies reports and records adverse events and product complaints in a timely manner in accordance with SOP.
- May be asked to provide medical review for promotional and/or medical materials
Responsibilities
Routine responsibilities may include the following
- Respond to unsolicited requests for medical and scientific information regarding the products and documents in the request handling system (MiQ)
- Researches and collaborates with cross functional colleagues to provide response to complex requests. TA specialist responds to complex requests from affiliate MI and internal colleagues
- Create update and participate in review and quality check of MI response documents in accordance with local laws and regulations
- MI specialist collaborates with affiliate MI and relevant internal partners who may include medical affairs development regulatory global patient safety and operations commercial to manage global response topics and content
- MI specialist prepares data on file to support response documents and complex requests
- Maintain document repository with regular/routine review of approved documents for new data from regulatory updates scientific conferences up-to-date literature searches proactive literature surveillance or newly published materials
- Understand the needs and preferences of internal and external partners and customers
- Review and provide analysis of MI databases for trends customer insights and data gaps to guide content development and prepare customer interaction reports to share with internal stakeholders
- May oversee and/or evaluate external consultant writers
- MI specialist provides process and product training to colleagues and vendors as required
- Support departmental strategic initiatives to address major activities within TA (product launches labelling updates patient engagement etc.)
- Identify report and record adverse events and product complaints in a timely manner in accordance with SOP
- Participate in MI activities and projects in line with global and regional strategic MI plans
- Works under supervision of manager or colleague
Knowledge and Skills
- Excellent written verbal and interpersonal communication skills and the ability to work well in multidisciplinary teams across geographies
- Ability to create and provide clear communication of scientific data for different audiences including members of the public
- Knowledge and understanding of the clients marketed and investigational products
- Knowledge of applicable regulatory and legal requirements for the provision of MI in the pharmaceutical environment with understanding of regional or country regulations related to the provision of MI services
- Ability to provide analysis and evaluate clinical biomedical and scientific data
- Ability to develop and maintain good working relationships with departmental and cross-functional colleagues
- Understanding of internal and external stakeholder needs and priorities
- Serve as an advocate for MI affiliate or Global MI
- Demonstrates client s core values and Leadership Commitments
- Has a strong attention to detail excellent project management and problem-solving skills and ability to think creatively
- Good organizational and work planning skills and ability to manage multiple projects in a fast-paced environment
- Awareness of digital solutions for communicating with healthcare providers and patients
- Previous experience with problem-solving and project management preferred
Education and Experience
- Pharmacy Nursing or Medical/ Life Sciences degree/advanced degree or equivalent (PharmD preferred)
- Experience in MI or working in a healthcare environment preferred.
- Experience in the pharmaceutical industry or a MI vendor preferred.
- Experience in Cell Therapy Hematology or Oncology preferred
TekWissen Group is an equal opportunity employer supporting workforce diversity.
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