* Validation Testing
* LIMS
* Validation of Medical Devices
* ERP Validation
Relevant Exp: 3 to 5 years (Validation & Life Sciences exp)
Work Location: Hyderabad
The complete details for the Life Sciences Consultant opening are:
Deloitte & Touche LLP's ("Deloitte & Touche's") Governance, Regulatory & Risk Strategies (GR&R) services help organizations and their boards manage their business risks on a sustained basis. We assist our clients in assessing their enterprise-wide risks and help them develop a sustainable compliance and risk management program by coordinating the utilization of people, process and technology to improve effectiveness and manage costs. The services/solutions we provide include the following:
* Governance Services
* Enterprise Risk Management Services
* Regulatory & Compliance Services
Our Life Sciences Industry sector is a global leader in delivering risk management solutions and performance improvement to a variety of life science companies and health care organizations including services related to the regulation of product promotion, GXP and FDA regulation and/or compliance. As a result of rapid growth, we are seeking a qualified Consultant to join our team in the Hyderabad office.
Responsibilities include:
* Provide engagement management and/or participate in development of methodology
* Play lead role in client retention, relationship building, and communication
* Play lead role in internal and external communication/deliverable quality including technical content of reports, proposals, etc.
* Develop, participate in, and deliver client proposals
* Demonstrate high level of understanding of clients business
* Demonstrate strong knowledge in industry or functional specialty
* Play lead role in management planning, economics, and billing
* Assist engagement leader to determine service specifications
* Deliver services that meet Deloitte & Touche's engagement leader specifications
* Meet assigned sales target/team sales targets
* High visibility in functional or industry specialty
* Participate in professional & civic organizations
* Produce material for internal and external publications
* Participate in public speaking in internal and external events
* Mold the individuals on the engagement into a team
* Responsible for oversight or advisee on training and development program
* Evaluate, counsel, mentor and provide feedback on performance of others
* Play substantive/lead role in retention of professionals and in building staff complement, mix, and recruiting
* Play substantive/lead role in developing a strong relationship with internal resources
Desired Skills
* 3+ years Life Sciences experience (Pharmaceutical, Medical Device, Biotechnology) focusing on the regulation of product promotion, FDA regulation and/or compliance
* Prior experience in developing and evaluating one or more compliance programs including but not limited to: PhRMA Compliance, OIG Compliance, Sales and Marketing Promotional Compliance.
* Experience and knowledge in developing and delivering formal compliance training through various methods including formal presentations, on-line training, workshops, written materials.
* Knowledge of regulatory, legal, ethics, guidelines and compliance in the Life Sciences industry and proactively stays abreast of emerging compliance trends in the pharmaceutical, biotechnology and medical devices sectors.
* Deep industry experience in one or more of the following:
o Prescription drug advertising and promotion
o Off-Label Promotion
o Dispute resolution
o FDA regulation
o GXP Compliance including GCP, GLP, and GMP
* Monitoring and auditing programs for sales and marketing activity
* Proficiency in MS office products, including Excel, Word and PowerPoint
* Strong verbal and written communication skills, technical and organization skills
* Candidates who have in-depth knowledge of regulatory compliances viz. FDA, 21 CFR PART 11, MHRA, MHEA, ISO with IT (QA/QC) exp. in either of the following.
Candidates can send their profile to jpabhishek@searchlight.co.in or call me @ 040-40101210/11.
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