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Senior Associate - Primary Market Research

Job Description:

We are looking for dynamic Primary Market Research professionals with hands-on experience in planning, designing, executing and analysing the primary market research projects in Pharmaceutical industry. The ideal candidate must have solid primary market intelligence experience with experience working on diverse products, therapeutic areas in global markets (USA, EU, Asia and others)

The candidate must have,

· Ability to write screeners, discussion guides and questionnaires

· Ability to reach out participants and acquire intelligence based on questionnaire

· Strong communication skills and ability to engage audience on phone or in person

· Ability to conduct qualitative analysis from transcripts and/or content analysis

· Ability to interpret quantitative data from excel based data tables

· Ability to develop PowerPoint presentations to report back the findings of the research in a clear and ‘storylined’ manner that directly answer the research objectives

Technical/Functional Skills:

The candidate is expected to have at least 2-5 years of relevant experience in the following functional areas in a large organization:

· Strong academic background - minimum of degree level education from a good university, preferably in biological sciences related discipline

· Minimum of 2-3 years’ experience in international pharmaceutical market research

· Must have worked in strategic engagements either with corporate strategy teams or in consulting firms.

· Should have strong Primary Research (Qualitative, Quantitative) capabilities.

· Acumen for stakeholder management with ability to work with a diverse range of teams from various geographies

· Exceptional analytical and report writing skills, and proficient in using PowerPoint to present complex data visually

· Strong structured problem solving and analysis skills

· Excellent verbal and written communication skills

· Meticulous attention to detail and strong organizational skills

Job Description:

-3-5 years of regulatory affairs experience in the pharmaceutical industry
•Prior experience preparing and reviewing submissions to FDA
•Ability to work independently, take initiative and complete tasks to deadlines
•Ability to work within a matrix team environment
•Strong written and verbal communication skills with good attention to detail
•Good organizational skills and demonstrates effective time management
•Desire to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
•Up to 10% travel is required based upon business needs

Responsibilities

•Reporting to the Sr Director, Regulatory Affairs, the Manager, Regulatory Affairs will be primarily responsible for supporting tactical activities related to regulatory deliverables (ie, compilation and review of submissions to Health Authority, coordination of activities to support regulatory interactions, etc.). This individual will work closely with the regulatory strategy leads across functions and development programs
•Track and manage all routine Health Authority (HA) submissions (ie, Annual Report, Periodic Safety Report) and initiate kick-off meetings, as appropriate
•Track and manage all IND maintenance submissions (ie, Information Amendment), including routine tracking of newly issued reports for incorporation into annual updates (ie, Investigator’s Brochure [IB] and Investigational Medicinal Product Dossier [IMPD])
•Under the leadership of the regulatory strategist assigned:
•support all HA submissions across all programs (i.e., preparation of submission cover letter and applicable forms and review of published submission)
•manage cross-functional meetings to discuss and update regulatory deliverables (ie, Meeting Requests/Briefing Document, Pediatric Development Plans, prescribing information, etc.)
•Lead regulatory intelligence activities, including issuance and maintenance of a regulatory intelligence database

· Should have strong Primary Research (Qualitative, Quantitative) capabilities.

· Acumen for stakeholder management with ability to work with a diverse range of teams from various geographies

· Exceptional analytical and report writing skills, and proficient in using PowerPoint to present complex data visually

· Strong structured problem solving and analysis skills

· Excellent verbal and written communication skills

· Meticulous attention to detail and strong organizational skills

Regulatory Affairs Manager