Scientist, Medical Affairs

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 li