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Executive / Senior Executive - LMS

Full-Time

Hyderabad, India

Bengaluru, India

Description

Role Summary:
With limited supervision, serve as a site administrator for the Learning Management System (LMS) used to manage training for client and support across North America for the organization.Accountable for creating learning activities and assigning curricula as requested by site management, ensuring that they are deployed accurately and in alignment with current standard operating procedures. Add personnel to LMS user groups or other existing user groups.Answer users’ questions regarding operation of the LMS and assist users with systems access troubleshooting. Monitor and report to site and/or training management the training completion status, gaps, and other metrics as required.Coordinate training records (electronic and/or hard copy) and provide training records/reports as required to support regulatory inspections and audits.


Primary Responsibilities:

  • Administer all training in the LMS, including creating curricula user group maintenance, loading and testing content and management of electronic and/or hard copy training records.
  • Interface/communicate with functional area management for accurate group/individual training requirements.
  • Respond to all requests and inquiries regarding training record, employee qualifications, reports and metrics.

Additional Responsibilities:

  • Staff meetings
  • One-on-one meetings
  • Project work
  • Troubleshooting
  • RQC (Request for Access) for systems (e.g. SAP)
  • User training, certifications & support on use of LMS

Candidate Profile:

  • High School (or equivalent) education required.
  • Bachelor’s degree (or equivalent) desirable.
  • Should be 2-3 years of relevant training or quality experience with 5 years overall business experience required.
  • Experience working in a highly matrixed, global organization is critical for success.
  • Experience with Learning Management Systems (e.g. ComplianceWire, CornerStone On-Demand) strongly preferred.
  • Excellent organizational, verbal and written communications skills are required.
  • Demonstrated problem solving skills and proven ability to develop and maintain effective business partnerships is a requirement.
  • Other skills desired:Curriculum design.
  • MS Office Suite (Word, PowerPoint, Excel, Outlook).
  • Knowledge of SharePoint administration.
  • Development of training metrics and conducting data analysis.
  • Demonstrated time management.
  • Customer service skills
  • Training delivery experience and/or demonstrated effective presentation skills.
  • General knowledge of Quality Systems processes and applicable regulations.
  • Strong business partnering skills.
  • Process and detail-oriented.
  • Managing achievement of competing priorities and deadlines.

Pharmacovigilance Physician / Senior Pharmacovigilance Physician

Full-Time

Bengaluru, India

Hyderabad, India

Description

Job Description:

  • Perform medical review of non-serious, serious and potentially serious ICSR with emphasis on seriousness, expectedness, causality & narrative etc. without missing on quality & compliance.
  • Support triage of cases and determine seriousness and relatedness across products as assigned.
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate MedDRA code, assess labelling, review narrative.
  • Acquire and maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas. Involve in process improvement activities like implementation of quality control process.
  • Provide medical guidance and expert opinion on the cases to the data entry associates and peer reviewers to help in resolving queries.
  • Identify and resolve case issues, coordinate with client therapeutic teams and within functional team and manage as appropriate.
  • Maintain PV expertise, and understanding of international safety regulations and guidelines.
  • Provide strategic and proactive safety input into development plans.
  • Support due diligence activities and pharmacovigilance agreements.
  • Responsible for completing the MR activities in safety database within the stipulated time.
  • Provide feedback to case processors on the errors/ discrepancy noted.
  • Ensure timely and appropriate regulatory submissions.

Candidate Profile:

  • MBBS / MD with 1-4 years of experience as Medical Reviewer.
  • Expert level knowledge and hands-on experience in individual case safety report medical evaluation, coding, documentation, and submission to health authorities.
  • Advanced level understanding of international Pharmacovigilance Regulations.
  • Excellent written and verbal communication skills in English.

Statistical Programmer / Senior Statistical Programmer

Full-Time

Bengaluru, India

Hyderabad, India

Description

Job Responsibilities:

  • This role reports to the Associate Manager – Statistical Programming, and above.
  • Produces statistical analysis using SAS/R according to relevant standard operating procedures.
  • Ensuring compliance to SOPs.
  • Programming analysis dataset without specifications.
  • Delivers the assigned tasks and projects within agreed timelines and quality standards.
  • Developing SAS Programs for the statistical analysis of study data, including analysis of datasets, tables, listings, and figures.
  • Programming according to CDISC SDTM and ADaM datasets.
  • Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
  • Create an electronic submission package to FDA, e.g., Patient Profile or Subject Narratives, ISO Listings, define.xml, or define.pdf following FDA guidelines.
  • Preparing and performing internal training on statistical programming processes and techniques
  • Make certain, that indication or project documents and specifications are consistent and comply with company/client standards by providing the inputs into study SAP, Protocol, CRF, and outputs.
  • Provide guidance, mentoring, training for junior team members and help solve issues from cross-functional teams.
  • Represent ClinChoice/Department during internal and external audits.
  • Communicating effectively with the internal project team and global team. Collaborate closely with the study/working group.
  • Reporting issues to the Project or Study leads or Supervisors in an appropriate timeframe.
  • Responsible for continuous development of own skills according to Individual development plan.
  • Actively present in knowledge-sharing meetings, ask questions, and share feedback to improve the process or standards of the programming continuously.
  • Proactively communicate and collaborate with the global team by understanding the time zone differences.
  • Conducts other statistical programming activities as required.
  • Conduct other administrative and departmental activities as needed.

Candidate Profile:

  • Bachelor’s degree or equivalent required, preferably in life science, statistics, computer science, or related subjects.
  • Should have 2-7 years of experience in Statistical Programming within the pharmaceutical industry.
  • Good experience within the pharmaceutical industry with clinical programming and clinical development processes of across therapeutic areas.
  • Good knowledge and experience in study setups, different processes, tasks such as SDTM, SDRG, ADaM, ADRG, TFL, ISS/ISE, Define XML, ISO Listings, Macro Programming, etc. and analysis the requirements for clinical programming projects.
  • Good knowledge of Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology, e.g., ICH-GxP, E3, E6, etc.
  • Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc.
  • Good written and verbal communication skills, collaborations, and interpersonal skills.

Senior Executive / Specialist – Aggregate Reporting

Full-Time

Bengaluru, India

Hyderabad, India

Description

Primary Job Responsibilities :

  • Responsible for drafting of PBRER/PSUR for innovator products and devices for EMA and other local health authorities as per the requirement.
  • Co-ordinate with various stakeholders and conduct planning meeting and obtain the inputs required for drafting the PBRER/PSUR reports.
  • Address the comments of stakeholders and submit the clean copy of the report to Sponsor.
  • Manage the production of aggregate reports such as PBRER/PSUR etc. for assigned products – medium to high complexity reports.
  • Perform quality reviews for the reports prepared by the peer aggregate report writers.
  • Ensure preparation of timely, quality aggregate reports for assigned products.
  • Liaise with relevant stake holders as appropriate for preparing report content.
  • Data quality review /correction.
  • Quality review of team members aggregate reports.
  • Attend team meeting, department meetings, required training and relevant activities.
  • Awareness of global culture and drug safety.

 Secondary Job Responsibilities :

  • Complete all assigned trainings within specified timelines in the internal training tool and sponsor training tool.
  • Attend team meeting, department meetings, required training and relevant activities.
  • Keeping the trackers up-to-date and timely archival of documents in SharePoint.

Candidate Profile :

  • Should have done MPharm / PharmD / BDS / BPharm / MSc in Life Sciences.
  • Should have 2-6 years of experience.
  • Good understanding of ICH E2C (R2) and GVP module 7 guideline.
  • Hands on experience on drafting of PBRER/PSUR for innovator products.
  • Excellent written and verbal English communication skills.
  • Competent in use of desktop applications: Microsoft Excel, Word and PowerPoint.

Regulatory Toxicologist

Full-Time

Bengaluru, India

Hyderabad, India

Description

Primary Job Responsibilities :

  • Conduct literature searches and prepare toxicological assessments of various raw materials/ingredients used in consumer and OTC products. 
  • Creation of Toxicology Profiles for INCI ingredients as well as residual chemicals. 
  • Conduct risk assessment for raw materials for cosmetic applications including Margin of Safety and California Proposition 65 calculations. 
  • PDE Calculations.  
  • Draft Full Safety Assessments as required by the European Cosmetics Directive.
  • Draft safety assessments for impurities and degradants based on requirements.
  • Draft Full Safety Assessments including recommendation for approval of formulas.

Secondary Job Responsibilities :

  • Complete all assigned trainings within specified timelines. 
  • Participate in Process Improvement Initiatives to keep up the Quality and Compliance score. 
  • Escalate any issues for in the daily activities with the Lead on Daily Basis.

Candidate Profile :

  • Minimum of 1-10 years of experience in Pharmaceutical/FMCG/KPO industry.
  • Bachelor’s degree or higher in life sciences or related field; advanced degree(MVSC/M.Pharm/MSc/MS Pharm/PhD in Toxicology) preferred.
  • Good verbal and written communication and presentation skills in English.
  • Should be familiar with toxicological literature search databases and OECD guidelines.
  • Should be able to interpret toxicological data (systemic and local toxicity).
  • Should be able to differentiate with treatment related and non-treatment related effects in animals.
  • Should have experience in risk/hazard characterization of chemicals/residues.
  • Should have experience in drafting the reports.

Medical Writer - CSR (Clinical Study Report)

Full-Time

Bengaluru, India

Hyderabad, India

Description

Job Responsibilities :

The Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, and safety update reports, etc.The Medical Writer may provide writing support for more complex clinical documentation, with appropriate departmental supervision. The Medical Writer may serve as primary technical contact with client under appropriate departmental supervision.
Key responsibilities and skills may include, but are not limited to:

  • Serve as the primary client contact under departmental supervision.
  • Serve as the Medical Writing representative on assigned project teams, providing support to Project for developing efficient work plans and timelines for medical writing deliverables, and medical writing input into other departmental deliverables.
  • Providing support to Business Development Department for project bidding, document review and forecasting timeline.
  • Write clinical documents associated with submissions to regulatory authorities.
  • Serve as QCer to review peer`s clinical documents.
  • Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review.
  • Ensure document content and style adheres to appropriate regulatory guidelines and complies with departmental and corporate or client SOPs and style guidelines.  
  • Coordinate production and distribution of draft and final documents to project team and client.
  • Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
  • Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
  • Attend internal technical team and client team meetings as required.
  • Keep abreast of professional information and technology through workshops and conferences and ensure the appropriate transfer of that information to the department.
  • Participate in departmental or interdepartmental process improvement and training initiatives.
  • Other assignment duties as assigned by department management.

 

Candidate Profile :

  • Bachelor’s degree or above in Life Sciences/Health Related Sciences or equivalent.
  • Fluent in written and spoken English.
  • The candidate should have experience of the eCTD Module.
  • Experience in the pharmaceutical industry or medical writing.
  • Experience of 3-4 years of medical writing of regulatory documents such as CSR, protocol or similar in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.
  • Good clinical/scientific writing skills.
  • Excellent interpersonal, verbal and written communication skills.
  • Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
  • Good word processing skills/familiarity with Word for Windows.

Senior Executive\Specialist - Technical Writing

Full-Time

Bengaluru, India

Hyderabad, India

Description

Job Responsibilities :

  • Responsible for the writing of Clinical Evaluation Plans.
  • Responsible for compliant writing of Clinical Evaluation Reports within this business in accordance with local procedures, client guidelines and regulatory requirements.
  • Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, client guidelines and regulatory requirements
  • Ensures the CER and SSR files are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed.
  • S/He will develop, implement and manage an effective communication model for CERs/SSRs with cross functional business partners
  • Assists in the development of schedules to ensure operating company CER/SSR timelines are met.
  • Participates in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
  • Supports and at times acts as an SME during audits and inspections pertaining to CER/SSR processes and reports.
  • Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR process.

Candidate Profile :

  • Graduate or Post-graduate in Life-Sciences, with a minimum of 1-3 years of related job experience is required.
  • Experience within the medical device industry and knowledge of clinical evaluation report, regulatory requirements, evidence generation, and CER document creation is required.
  • Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common biostatistical methods is preferred.
  • Regulatory/Notified Body audit experience is preferred.

Medical Writer-SOA (State-Of-the-Art)

Full-Time

Bengaluru, India

Hyderabad, India

Description

Primary Job Responsibilities :

  • Participates in planning and executing the SOA outline/library
  • Perform literature activities, such as, screening, data extraction, analysis, and synthesis for the SOA libraries
  • Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries highlighting any new findings
  • Identifies new adverse events
  • Review the risk/benefit data to update SOA

 

Secondary Job Responsibilities :

In preparation for the SOA activities, the SOA Medical Writer is expected to perform general CER medical writing tasks – plans and executes general medical writing activities and systematic literature reviews primarily for the generation of Clinical Evaluation Reports (CER) for assigned therapeutic area and projects. The high-level activities may include:

  • Participates in the planning and execution of general medical writing activities and systematic literature reviews for assigned therapeutic area.
  • Prepares, writes, and edits creditable systematic literature reviews through the creation of protocols and reports in order to synthesize and analyze the clinical data from medical and scientific publications reporting on a range of medical devices.
  • Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes.
  • Performs data extraction of included studies into a data collection tool (e.g. Microsoft Excel, Distiller).
  • Utilizes software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, QUOSA, SAS) 
  • Extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports.
  • Organizes clinical data from literature into references, graphics, tables, and data listings. 
  • Critically synthesizes clinical data being considered for presentation in the final report. 
  • Performs scientific writing of the synthesized literature using templates.
  • Interprets and summarizes complex results from the medical and scientific literature and present them in clear, concise, and scientifically accurate manner to various end users requiring the ability understand and interpret statistical results of clinical studies.  
  • Presents the results of systematic literature reviews at internal meetings.

 

Candidate Profile :

  • Candidate must be MDS / M.Pharm / PhD.
  • 2-3 years of relevant training or quality experience with 5 years overall business experience required. 
  • Experience working in a highly matrixed, global organization is preferred. 
  • Excellent organizational, verbal and written communications skills are required.
  • Demonstrated problem solving skills and proven ability to develop and maintain effective business partnerships is a requirement. 
  • Candidate should have experience in MS Office Suite (Word, PowerPoint, Excel, Outlook).
  • Knowledge of SharePoint administration.
  • Process and detail-oriented.
  • Managing achievement of competing priorities and deadlines.

 

Principal / Lead Statistical Programmer

Full-Time

Bengaluru, India

Hyderabad, India

Description

Job Responsibilities :

  • Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
  • Develop SDTM specifications and generate SDTM datasets using SAS.
  • Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
  • Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
  • Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
  • Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
  • Analyze information and develop innovative solutions to programming and data analysis challenges.
  • Actively communicate with statisticians for statistical input and analysis interpretation.
  • Follow and reinforce regulatory agency requirements during daily job.
  • Serve as a programming team lead and contribute to department initiative.
  • Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
  • Review draft and final production deliverables for project to ensure quality and consistency.

Candidate Profile :

  • Master’s / Bachelor’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
  • Should have 8-13 years of experience in Statistical Programming in Clinical domain.
  • Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
  • Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
  • Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
  • In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Good understanding of clinical drug development process.
  • Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
  • In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Good understanding of clinical drug development process.
  • Detail-oriented and ability to learn and adapt to changes.
  • Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc

 

Senior Executive/Specialist-Marketing

Full-Time

Bengaluru, India

Description

Job Responsibilities:

1.Market Research:

  • Perform periodic and ad-hoc research to identify new opportunities.
  • Review health authority websites to identify regulatory changes, updates, and notifications.
  • Assess the competitor landscape to support internal SWOT exercises. 

2.Contact Database Creation:

  • Create a database of decision-makers by surveying publicly available sources.
  • Periodically maintain and update the database.

 3.Email Campaigns:

  • Execute email campaigns per the marketing calendar.
  • Ideate new approaches to improve open and click rates.
  • Use/learn HubSpot to execute email campaigns.

 4.Stakeholder Engagement:

  • Collaborate with the sales team to fine-tune research requirements.
  • Present weekly reports about the research to the sales team

Candidate Profile :

  • Candidate must be a B.Pharm / M.Pharm with or without MBA.
  • Candidate should have 4-6 years of experience.
  • Proficiency in MS Office is mandatory.
  • Prior experience with HubSpot or equivalent platform is desirable.
  • Excellent verbal communication and strong writing skills in English.
  • Accountability and responsibility for delivery of quality results which support internal and external needs of the project.
  • Excellent attention to details and accuracy with demonstrated analytical and conceptual skills.
  • Managing own work: ability to prioritize, plan and organize multiple assignments and to work under strict timelines with minimal supervision.