Scientist, Medical Affairs

JOB_REQUIREMENTS

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Company Location

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Salary

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Job Title

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.

Secondary Responsibilities:

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

Skills and Qualifications