Responsibility:
Analyze internal sales data, internal and external marketing and prescriptions data, from providers, to provide estimates of patient exposure to client marketed products.
Compare exposure estimates from last report to current report, identify inconsistencies, and resolve them. This may require obtaining corrected or additional input data for consumer products, recalculating previous exposure estimates, or confining that appropriate units were used in the calculations.
QC exposure estimate reports for products prepared by other colleagues. Document exposure algorithms used, errors encountered, and discrepancies resolved for products supported by the Exposure team.
Send out reports to requestors, track tickets and reports completed for PSURs and Health Authorities world-wide, track previous vs. current exposure estimates for new products taken on by the exposure team, additional QC and follow-up with internal/external colleagues as appropriate. Document how data were used to generate estimates.
Participate in cross-functional development of analytic services, other support duties as assigned.
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
Ensure compliance of operations with governing regulatory requirements
Create, maintain and assume accountability for a culture of high customer service
Efficiency in conducting literature searches for authoring various types of reports
Write and review various safety reports (or part of such reports) for global regulatory submissions for Covance's clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents, as assigned.
Perform/review Signal detection activities
Author/ review RMPs, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
Act as a writing coach, devise training programs
Author/review SOPs/WIs/process documents or sections as applicable.
Impart/conduct Trainings for peers and team members
Coordinate activities related to various types of report writing across a team of writers if applicable
Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training
Assist in estimation of resource requirement and responding to RFPs as needed
Internal and external (client) communication & co-ordination to get the required inputs
Get resolution on issues affecting project deliverables
Any additional activities as per the project requirement or manager's discretion on completion of relevant trainings
Education & Qualifications:
Master's degree in Pharmacy/related science area
Bachelor's degree in Medical Science
At least 5 years' experience in the pharmaceutical industry, with at least 3 years of it in medical writing
Experience in drug discovery and pharmacovigilance is desirable
Drug discovery and development
Clinical Research, Pharmacovigilance
Good understanding of regulatory requirements and ICH-GCP, GLP guidelines
Technical proficiency with Microsoft Office suite applications
Key Competencies
Clinical and Pre-Clinical Research, Good Clinical Practice, Good Laboratory Practice
Strong working knowledge of anatomy, physiology, disease states, medical treatments and procedures
In-depth knowledge of medication names and drug therapy
Thorough understanding of drug safety and management of benefit/risk assessment
Orientation to pharmacokinetic, pharmacodynamic and toxicology principles
Strong written and verbal language skills
Ability to analyze and synthesize medical information
Basic understanding of statistical concepts
Concern for quality, detail orientation
Coaching and mentoring of other team members
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
For more information about how we collect and store your personal data, please see our
Laboratory Corporation of America
Analyze internal sales data, internal and external marketing and prescriptions data, from providers, to provide estimates of patient exposure to client marketed products.
Compare exposure estimates from last report to current report, identify inconsistencies, and resolve them. This may require obtaining corrected or additional input data for consumer products, recalculating previous exposure estimates, or confining that appropriate units were used in the calculations.
QC exposure estimate reports for products prepared by other colleagues. Document exposure algorithms used, errors encountered, and discrepancies resolved for products supported by the Exposure team.
Send out reports to requestors, track tickets and reports completed for PSURs and Health Authorities world-wide, track previous vs. current exposure estimates for new products taken on by the exposure team, additional QC and follow-up with internal/external colleagues as appropriate. Document how data were used to generate estimates.
Participate in cross-functional development of analytic services, other support duties as assigned.
Implement and promote use of consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures, and assume accountability for the deliverables
Ensure compliance of operations with governing regulatory requirements
Create, maintain and assume accountability for a culture of high customer service
Efficiency in conducting literature searches for authoring various types of reports
Write and review various safety reports (or part of such reports) for global regulatory submissions for Covance's clients, including Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Periodic Benefit-Risk Evaluation Reports, Bridging reports and other clinical documents, as assigned.
Perform/review Signal detection activities
Author/ review RMPs, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
Act as a writing coach, devise training programs
Author/review SOPs/WIs/process documents or sections as applicable.
Impart/conduct Trainings for peers and team members
Coordinate activities related to various types of report writing across a team of writers if applicable
Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training
Assist in estimation of resource requirement and responding to RFPs as needed
Internal and external (client) communication & co-ordination to get the required inputs
Get resolution on issues affecting project deliverables
Any additional activities as per the project requirement or manager's discretion on completion of relevant trainings
Education & Qualifications:
Master's degree in Pharmacy/related science area
Bachelor's degree in Medical Science
At least 5 years' experience in the pharmaceutical industry, with at least 3 years of it in medical writing
Experience in drug discovery and pharmacovigilance is desirable
Drug discovery and development
Clinical Research, Pharmacovigilance
Good understanding of regulatory requirements and ICH-GCP, GLP guidelines
Technical proficiency with Microsoft Office suite applications
Key Competencies
Clinical and Pre-Clinical Research, Good Clinical Practice, Good Laboratory Practice
Strong working knowledge of anatomy, physiology, disease states, medical treatments and procedures
In-depth knowledge of medication names and drug therapy
Thorough understanding of drug safety and management of benefit/risk assessment
Orientation to pharmacokinetic, pharmacodynamic and toxicology principles
Strong written and verbal language skills
Ability to analyze and synthesize medical information
Basic understanding of statistical concepts
Concern for quality, detail orientation
Coaching and mentoring of other team members
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
For more information about how we collect and store your personal data, please see our
Laboratory Corporation of America
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Manila City, Metro Manila
Permanent
Full-time
Permanent
Full-time
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Laboratory Corporation of America
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Position senior Medical writer recruited by the company Laboratory Corporation of America at MetroManila, Manila, Joboko automatically collects the salary of , finds more jobs on Senior Medical Writer or Laboratory Corporation of America company in the links above
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