Description
- Is required to obtain and maintain full proficiency and knowledge of disease state, product and other aspects or issues as provided for and mandated by the company
- Stays abreast of internal and external developments, trends and dynamics, as these potentially implicate or evolve the development, launch and/or post-marketing medical direction of the assigned molecules/products, franchise(s), and/or overall therapeutic area(s). Includes maintaining a basic understanding of legal and regulatory topics relevant to healthcare/pharmaceutical/biotechnology industries
- Maintains a high standard and level of clinical knowledge in the specific therapeutic area(s) of assignment; reviewing and keeping updated on scientific/medical journals and other relevant publications and continuous communication and effective partnering with various groups
- Works with supervisor and other partners/stakeholders to evaluate development, launch and post-marketing strategies to determine medical communications needs and align MC Operations plans, projects, other tactics and resources:
- Builds and maintains relationships with internal customers, partners and other stakeholders. Attends and participates in a host of cross-functional meetings. Provides an in-depth MC Operations perspective, inputs and recommendations in the ongoing development and management of medical communications for molecules/products in the assigned therapeutic area(s)
- Participates in special projects, as assigned
- Ensures consistent compliance with all corporate and other governing policies, procedures, regulations, laws and other pertinent guidelines for all medical communication activities
- Acts as a MC Operations expert and resource to internal and external customers and consistently approaches interactions with clinical integrity and the highest professional ethics; consistently advocates for scientific accuracy and compliance
- Participates in departmental teams and may participate in cross-functional teams
- Where assigned and applicable, may act as a standing member of cross-functional teams or work groups
- Depending upon areas of assignment, may perform some or all of the following activities for assigned molecules/products:
- Ongoing literature surveillance across multiple sources
- Conducting literature and other information searches
- Downloading and reviewing literature for relevance
- Maintaining and managing current and accurate documentation and data in MC systems and databases
- Triaging internal and external requests for medical information regarding the company's products. Includes assistance to Trial Inquiry Support Manager to support the companys's clinical portfolio
- Overseeing external vendor operations that support MC as the first line response to inquiries and requests for medical information from HCPs, payers, patients, or potentially others
- Monitoring vendor inquiry documentation to ensure accuracy, legal, regulatory and general compliance with the company/Roche standards, policies, procedures and protocols
- Providing external vendor partners with information they need to respond to external medical information requests
- Routing and/or otherwise managing escalated cases for the second line of response
- Recording and tracking cases for unsolicited requests and/or other relevant operations and metrics
- Running regular and/or ad hoc reports from MC systems and databases
- Supporting MC scientists in writing and maintaining medical responses to internal/external requests for information and to address other inquiries
- Supporting MC scientist in writing, maintaining and providing internal parties with product information and other relevant medical content to support them in their communications and interactions with HCPs, payers or other relevant external parties
- Supporting MC scientists in their review of promotional materials, reprint dissemination materials, MSL (Medical Science Liaisons) slide decks, and other relevant content from internal partners for external audiences
- Supporting MC scientists in writing and providing medical content for training purposes
- Identifying, communicating and addressing potential training issues, whether for internal MC Operations staff or external vendor partners
- Reviewing new publications and partnering with MC scientists to incorporate content into relevant medical documentation and information
- Completing other medical documentation, as assigned, which may include support in managing inputs into new publications or other scientific material
- As needed, provides additional medical communications/writing support to other internal customers, partners and stakeholders
- Completes other administration, as and when assigned
- Participates in team meetings and other forums. Prepares in advance and provides a specialist perspective/contribution to team and other group developments
QUALIFICATIONS & EXPERIENCE:
Bachelors Degree in life sciences or related disciplines and/or experience
Knowledge of medical terminology is preferred
Previous relevant industry work experience is a plus
Must demonstrate a high level of proficiency with Microsoft Word, Excel and PowerPoint
Aptitude to learn and/or basic knowledge of marketed products and compounds in late development within assigned therapeutic area
Has some understanding of, or aptitude to learn, pharma/biotech drug development processes (key functions involved and the path through development and into market)
Basic knowledge and understanding of rules and regulations impacting medical communications practices
Proven track record of meeting or exceeding objectives and goals
Business travel, by air or car, is required for regular internal and external business meetings
To find out more about Real please visit www.realstaffing.com