What are the responsibilities and job description for the Scientist, Medical Affairs position at ClinChoice?
Job Title
Scientist, Medical Affairs
Department
Medical Affairs/Medical Affairs
Responsibilities
Primary Responsibilities:
PhD in Nutritional is preferred
Scientist, Medical Affairs
Department
Medical Affairs/Medical Affairs
Responsibilities
Primary Responsibilities:
- Effectively organize and delegate work where applicable to complete the assigned tasks to meet deadlines
- Mentor and bestow domain knowledge to the team.
- Ensure the assigned tasks are delivered 100% on time or before, as per project SLA or Internal set threshold
- Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work
- Be able to independently perform tasks with minimal guidance & supervision
- Functionally review the team's work for accuracy and compliancee where applicable
- Ensure proper planning of the deliverable and foresee any risks that are likely to arise
- Ensure error free and 100% quality in assigned deliverables
- Ensure that all assigned goals [e.g. utilization and efficiency] are met as per set standards for the performance year
- Responsible to ensure training compliancee and timesheet compliancee
- Conduct functional training for the team members
- Support in the functional capability development of junior members
- Provides therapeutic area (e.g. Pain, Digestive Health, Smoking Cessation or UR/Allergy) knowledge support and clarification of science as needed and contributes to research activities via scientific publications.
- Conducts and evaluates literature searches and analyze scientific literature.
- Creates standard language for product information reference manuals including FAQs for new product launches, media issues, and publications.
- Provides medical support in reviewing the printed packaging components, labeling, and compendia.
- Collaborates with physicians as the medical representative on cross functional teams (copy clearance committees) to both marketed products and support to new marketed concepts for promotional and non-promotional pieces to ensure medical/scientific accuracy.
- Participates in creation of medical training materials and programs that are used to support initial and ongoing training for new employees.
- Trains employees who require in-depth scientific/medical knowledge of relevant products/therapeutic areas and in support of local and regional speakers upon solicited request.
- Creates and develops strategically targeted information in response to published scientific literature, news media releases, marketing initiatives, product recalls, or new or highly publicized medical discoveries or information.
- Assists in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS.
- Supports Investigator initiated studies including correspondence with investigators, researching the investigator site and facilitating review and approval of IIS proposals
- Performs quality review of the Epidemiology authored sections of the RMP and provides feedback on quality assessment finding.
- Effectively organize work to complete the assigned tasks to meet deadlines
- Ensure the assigned tasks are delivered 100% on time or before
- Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work
- Support in review of work done by peer teammates, on need basis.
- Alerts and escalates to senior members as required, whenever project deliverable risks are visualized, OR issues encountered impacting the delivery schedule
- Ensure error free and acceptable quality in assigned deliverables
- Responsible to ensure training compliancee and timesheet compliancee
- Ensure that all assigned goals [e.g. utilization, quality and timeliness] are met as per set standards for the performance year
- Follow and comply with the Company's Code of Conduct, Policies, and Procedures,
- Responsible for confidentiality, integrity, availability, and safeguarding of data,
- Responsible for reporting of security incidents and PIMS breaches as applicable,
- Comply with company QMS, ISMS and PIMS requirements and applicable regulatory requirements,
- Demonstrate adherence and compliancee to PIMS/GDPR requirements as follows: processed fairly, transparently, and lawfully; collected for specified and legitimate purposes; adequate, relevant, and limited to the specified purposes; processed in a secure manner
- Bachelor's degree in science or above and in alignment with project /
PhD in Nutritional is preferred
- Minimum of 5 to 8 years of relevant experience in identified functional domain/ business workstream
