Medical Affairs Clinical Research Scientist
Company OverviewAt Lilly, we unite caring with discovery to make life better for people around the world! We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 39,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first.! We’re looking for people who are determined to make life better for people around the world. #WeAreLilly
Through the application of scientific and clinical training and expertise, the Medical Affairs Clinical Research Scientist (CRS) is an integral member of the medical affairs team focusing on strategic planning in the support of launch and commercialization activities to meet patients’ needs and ultimately enhance the customers’ experience in interacting with the company. Specific activities include developing or contributing to the global and/or regional clinical/medical plan in his/her therapeutic area of responsibility, the development, conduct and reporting of local clinical trials or Real World Evidence Studies;, data mining, publications and other forms of data dissemination for products; advising on new and updated labels, consulting on documents and tools supporting product pricing, reimbursement, and access (PRA), reviewing grant submissions and contracts; participating in contacts with regulatory and other governmental agencies; engaging in outreach medical activities aimed at the external clinical customer community, including thought leaders; and various medical activities in support of demand realization. In addition, with input from the CRS Director-Medical and Business Unit Team Physician/Regional Medical Leader, the CRS is responsible for assuring that his/her activities are clearly aligned with the strategic priorities of the respective Medical Affairs Theraputic Area, Business Unit Brand team(s) and Global Development team.
The Clinical Research Scientist serves as a scientific resource for study teams, departments, and others as needed. The CRS is aware of and ensures that all activities of the medical team (and direct reports, if applicable) are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, and CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, global quality standards, the Principles of Medical Research and that activities are aligned with the medical vision.
Core Job Responsibilities – US Medical Affairs CRS
The primary responsibility of the Business Unit- Medical Affairs CRS is to provide expert scientific and clinical support to all aspects of the local business, to ultimately enhance the customers’ experience in interacting with the company. This includes local marketed product support (participate in the development of the “patient journey” and the strategic plan for the compound), medical support for regulatory affairs and interactions with government agencies medical support for PRA (providing medical guidance on the PRA plan and interacting with government PRA agencies as needed), providing medical expertise for evidence generation and leading in local scientific data dissemination (developing scientific disclosures, leading and presenting at conferences, advisory boards, etc., and overseeing the development of the scientific content of educational programs). These responsibilities are generally related to late-phase and marketed compounds.The CRS is responsible for collaborating with the global teams in the planning, startup and conduct of phase 3b/4 studies as well as non-clinical trial solutions/activities that are conducted in affiliates/countries as described in the clinical plan. In addition, the CRS, if assigned by the CRS Director-Medical, is responsible for support of global Development studies conducted in affiliates/countries.
The core job responsibilities may focus on those listed below as deemed appropriate by line management, as well as all other duties as assigned.
Business/ customer support (pre and post launch support)Scientific Data Dissemination/Exchange
Scientific / Technical Expertise and continued development
Clinical Research/Trial Execution and Support 53784BR
- An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following
- 3-5 years of clinical experience or
- 3-5 years of pharmaceutical experience (2 of which are in medical functions eg: Medical Affairs, Medical Information, Clinical Development etc)
Experience working with the creation, review and delivery of medical documents is preferred.
Have a BS or Masters degree in health/medical/scientific or related field and 5 years of pharmaceutical experience that is directly related to at least one of the following
- Medical Affairs
- Clinical trial experience
- Experience in areas relevant to drug discovery
- Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)
If experience is either in 3 and or 4 only (for example, no medical affairs experience), the following must be provided as supporting evidence of candidates ability/capability to perform in a CRS role
Clear evidence and documentation of candidate’s direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content = medical, scientific or clinical information)
- Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills
- Demonstrated strong communication, interpersonal, teamwork, organizational and negotiation skills
- Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.
- Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.
- Fluent in English, verbal and written communication
Additional Skills/PreferencesOther Information
Primary internal interactions include, but not limited to:
- Therapeutic area directors, managers, or project managers
- Product directors, managers, and associates of the brand
- Clinical research staff
- Scientific communication associates
- Medical information associates
- Medical liaisons
- Global patient outcomes research consultants/research scientists and health outcomes liaisons
- Regulatory directors, scientists, and associates
- Sales representatives
- Legal counsel
- Therapeutic area physicians, global brand physicians, early phase physicians, clinical research scientists, and Regional Medical Leader, Directors-Medical.
- Corporate or regional patient safety physician(s)
- Scientific and clinical experts, thought leaders
- Lilly clinical investigators
- Practicing physicians/prescribers
- Regulatory agency personnel
- Professional association staff and leaders
- Disease advocates and lay organizations focused on relevant health issues
- Formulary representatives (private and government)
- Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
- Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities participate in the workforce and ensure equal opportunity to compete for jobs. If you are an individual with a disability and require a reasonable accommodation to participate in the application process, please email Lilly Recruiting Compliance. Please note, this email address is intended for use only to request a disability accommodation, please email Lilly Recruiting Compliance for further assistance. Inquiries which are not requests for accommodations may not receive a response.
To submit resume, visit https://www.lilly.com/careers and apply to Req ID 53784.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
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