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Olympus Corporation of the Americas Global Lead, Medical Affairs in Westborough, Massachusetts

Working Location: Nationwide

Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.

Let’s inspire healthier lives, together.

Job Description

The Global Lead of Medical Affairs is part of Medical and Clinical Affairs (MCA) and reports directly to the Global Head of Medical Affairs. This position is responsible for the global medical/scientific Urology Therapeutic Area (TA) strategy, product portfolio and contributing to clinical development programs. As a physician, this role requires applying clinical knowledge and training to lead peer-to-peer engagements with medical experts and be responsible for managing the TA Medical Affairs team who are responsible for driving medical innovation, identifying clinical insights, and validating the value propositions for Olympus’ products.

Job Duties

  • Plan, manage and execute medical strategy through internal and external stakeholder engagement, while providing systematic and valid clinical evidence to ensure that the strategy is clearly defined and consistent with business objectives.

  • Conceives, develops, and implements strategies to support Olympus’ strategic and financial goals by building productive professional relationships with the medical community to identify unmet customer needs and promising business opportunities involving emerging medical and health care practices.

  • Gives medical/scientific input into Business Development, R&D, marketing, and Endoscopic Solutions Division (ESD)/Therapeutic Solutions Division (TSD) strategies, based on her/his medical expertise, and guides teams to understand what is medically important in product design, development, and lifecycle management.

  • Provides global medical leadership to ensure alignment of MSA strategies and activities across the phases of product development, including preclinical and clinical studies, market access, professional education, and product safety to ensure MSA objectives are fulfilled.

  • With the Global Lead of Scientific Communications, develops and executes strategic communication plans in her/his TA involving abstracts, presentations, and manuscripts for all ESD/TSD products involving Olympus-sponsored clinical studies.

  • Owns the global TA Medical Affairs strategy and drives harmonization globally while accommodating for differences in regional implementation.

  • Collaborates with, oversees, and prioritizes deliverables from Regional Leads, Medical Affairs, and is accountable for reconciling major regional medical differences that may exist regarding patients, healthcare professionals, and healthcare systems, into respective global ESD/TSD strategies.

  • Engages with cross-functional team members in Clinical Affairs, Operations Center of Excellence, Professional Affairs, Health Economics and Market Access, R&D, Regulatory, and Medical Safety to review clinical evidence and to evaluate a product’s risk-benefit calculus.

  • As a member of the MCA leadership team, is responsible for contributing to the MCA mission and objectives, and strategy over a 3- to 5-year time horizon and is accountable to the Global Head of Medical Affairs.

  • Develops and works to continually improve Medical Affairs’ infra-structure, including development of SOPs, best practices, and training and workshops.

  • Provides leadership, career development, coaching and mentoring to direct reports as well as developing a succession plan.

Job Requirements

REQUIRED QUALIFICATIONS:

  • Medical Doctor (MD), or non-US equivalent of M.D.

  • Minimum of 7 years of biotechnology/pharmaceutical/medical device industry experience in medical affairs, medical technology, medical strategy with experience in late-stage development projects and regulatory space or combination of relevant clinical practice, training, and education.

  • Domestic and international travel 40%, including weekend and evening travel as needed.

PREFERRED QUALIFICATIONS:

  • MD/PhD, MBA preferred with clinical training or doctoral degree in respective clinical speciality and therapeutic area of focus for Olympus.

  • Demonstrated deep knowledge of the therapeutic area and global understanding of medical affairs, clinical evidence development and global healthcare delivery systems.

  • Demonstrated success in product support and ability to bring strategic insight to commercialization plans in respective therapeutic area.

  • Demonstrated track record of executing medical and/or scientific plans in support of product differentiation, addressing healthcare stakeholder needs, and clinical practice patterns on a global level.

  • Demonstrated ability to understand current evolving environmental and market access issues.

  • Demonstrated success working in a matrixed organization, partnering with multiple internal & external stakeholders to deliver against the business unit strategy.

  • Strong knowledge and application of ICH GCP, GxP, ISO 14155, global regulations and good document management practices preferred.

  • Ability to think strategically, critically analyse and synthesize complicated data and scientific information.

  • Strong consulting, facilitation, and communication skills bridging between scientific and business priorities, to manage effective international and cross-divisional collaboration.

We realize work isn’t just a job to you.

It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.

Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.

Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com .

Olympus…True To You. True To Society. True To LIFE.

It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.

Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||

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