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 Labcorp\xe2\x80\x99s clients, including Annual Reports (IND and other), Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned
Perform/ review Signal detection activities
Author/review RMP, ad hoc reports, Safety Update reports, Benefit-Risk Evaluation, CCDS supporting document, ACOs, Addendum reports
Author/ review Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned
Author/ review Investigator Brochures, Protocols, Informed Consent Forms (ICFs), and Case Report Forms (CRFs)
Author/ review Clinical Study Reports for Phases 1-4 trials, including full study reports, abbreviated reports, web synopses, subject narratives
Author/ review manuscripts, abstracts, posters for conferences
Prepare/review medical information responses for HCPs
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
Liaise with client and act as a primary point of contact for all report writing activities
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
Creating and updating labels, e.g. Core Data Sheets, USPI, centralized SPC\xe2\x80\x99s, Med Guides
Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document
Any additional activities as per the project requirement or manager\xe2\x80\x99s discretion on completion of relevant trainings
Qualifications
Bachelor\xe2\x80\x99s/Master\xe2\x80\x99s degree in Pharmacy/related science area OR Bachelor\xe2\x80\x99s degree in Medical Science
Experience
At least 5-12 years\xe2\x80\x99 experience in the pharmaceutical industry, with at least 4 years of it in safety writing
Experience in drug discovery and pharmacovigilance, aggregate reports required - Ability to analyze and synthesize medical information
Experience on complex molecules or Pharma therapeutic segments preferable
Strong written and verbal language skills
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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