Strategy Insights & Planning Consultant: RDE Medical Affairs
Z's Associates, Inc

Job Info

---

ZS is a professional services firm that works side by side with companies to help develop and deliver products that drive customer value and company results. From R&D to portfolio strategy, customer insights, marketing and sales strategy, operations and technology, we leverage our deep industry expertise and leading-edge analytics to create solutions that work in the real world. Our most valuable asset is our people-a fact that's reflected in our values-driven organization in which new perspectives are integral and new ideas are celebrated. ZSers are passionately committed to helping companies and their customers thrive in industries ranging from healthcare and life sciences, to high-tech, financial services, travel and transportation, and beyond.

ZS' Business Consulting group delivers solutions to a broad spectrum of sales and marketing challenges. We also help our clients transform their sales and marketing strategies and organizations to improve their effectiveness. Our recommendations and solutions are based in rigorous research and analysis underpinned by deep expertise and thought leadership across the demand generation process.

ZS R&D Excellence Practice brings together experts in Strategy, Clinical Execution, Data Sciences and Technology to empower client organizations achieve their passion for patient care, science and business success. Through our Lifecycle Evidence Strategy, Clinical Trial Optimization, Medical Affairs and Real World Evidence services, we deliver impact where it matters, from early drug development to commercialization. This role will be aligned with ZS R&D Excellence Practice Area supporting our Technology and Platform services across multiple clients.

STRATEGY INSIGHTS & PLANNING CONSULTANT/ R&D MEDICAL AFFAIRS

ZS Consultants support our clients' clinical research activities and ensure productivity and efficiency in their research operations.

Responsibilities:

• Leverage knowledge of Life Sciences R&D organizations, data and systems, business processes and stakeholder types to aid analyses and recommendations for strategic solution offerings;
• Have a significant direct client interaction, managing multiple projects simultaneously;
• Apply advanced analytics (predictive and prescriptive) and data management knowledge on clinical data sources (both internal CDMS & CTMS and real world data) to provide insights for Clinical Trial Optimization;
• Represent R&D business in Clinical Trial Optimization and drive innovation, business case development, and lead user needs assessment workshops and roadmap development for existing and new opportunities;
• Build ongoing client relationships with key business users and leaders including client presentations
• Manage and advise the clinical needs assessment and requirements gathering process by meeting with stakeholders to define the business and functional requirements following user centric design best practices;
• Drive methodology and frameworks for Clinical Trial Optimization solutions
• Advise on clinical business process enhancements based on experience/best practices, business knowledge, and gaps in current vs. future state;
• Coach the cross-functional project team on the business perspective and data domain to inform key project decisions;
• Coach and mentor teams, conduct & develop training programs to contribute to capability building and knowledge sharing

Qualifications:

• MBA with bachelor's (and often graduate) degrees with a strong academic record in business, medical or life sciences, engineering, applied math, statistics or related fields. Alternately, candidates may possess a Masters (preferably PhD) in pharmaceutical sciences, decision sciences or related field with a business application. In lieu of an MBA or PhD, 5-8 years of relevant work experience may substitute;
• Up to 3 years of post-MBA relevant work experience, and 3-5 years of pre-MBA work experience in the Life Sciences industry with R&D expertise;
• Expertise in the areas of clinical research coordination, operations, risk based and centralized monitoring analytics;
• Knowledge of patient centricity in drug development (patient care eco-system, recruitment process, consent process, patient communication etc.)
• Hands on experience working with eClinical systems and data including CTMS, EDC, ePRO, CDMS, IVR, clinical registries and real world data (RWD).
• Experience support study managers working with CROs and/or working within a CRO or clinical study vendor organization
• Experience managing, developing and coaching team members
• Working knowledge of data standards like CDISC (ODM, SDTM, ADaM), OMOP and metadata management models like ISO11179 etc. and international regulations including 21CFR Part 11 and HIPAA

Additional skills:

• Understanding of Pharmacovigilance and Drug Safety, clinical submissions and regulatory areas of drug development
• Up to speed with latest industry trend in pragmatic interventional trials, hybrid data collection process, and data management with Clinical and R&D specifically.
• Superior verbal and written communication, organization, analytic, planning and leadership skills.
• Ability to distill complex concepts into easy-to-understand frameworks and presentations.
• Willingness to travel to other global offices as needed to work with client or other internal project teams.

ZS is a global consulting firm. Fluency in English is required; additional fluency in at least one European or Asian language is desirable.

Candidates must possess work authorization for their intended country of employment. An on-line application, including a full set of transcripts (official or unofficial), is required to be considered.

ZS offers a competitive compensation package with salary and bonus incentives, complete medical/dental/life insurance programs and retirement savings benefits. We are an Equal Opportunity Employer.

ZS is committed to providing and maintaining a safe workplace. Must have received or be willing to receive the COVID-19 vaccination by date of hire to be considered. Proof of vaccination will be required. Religious/Medical Exemptions can be requested on a limited basis upon hire.

NO AGENCY CALLS, PLEASE.

This job has expired.