Associate Director, Medical Reviewer

  • published till: 2022-07-13
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Company Background

At MorphoSys, we are motivated by our mission: More life for people with cancer. As a global, commercial-stage biopharmaceutical company, we are driven by the urgency to discover, develop, and deliver groundbreaking medicines, aspiring to redefine how cancer is treated.

Our success is created by our people, and we bring together exceptional talent from around the world, offering our colleagues a collaborative, flexible, and diverse work environment. We are looking for individuals who share our values and are motivated to improve the lives of people impacted by cancer.

Since opening our U.S. office in Boston in 2019, we have doubled in size to support our rapid growth, building teams of experts across a variety of different disciplines, from drug development to commercialization.

To learn more, visit us at www.MorphoSys.com, and follow us on Twitter and LinkedIn.

Job Summary & General Responsibilities

The AD/Medical Reviewer is responsible for the review of US medical and promotional materials from the medical perspective via MorphoSys Legal, Medical and Regulatory (LMR) Review Committee process. This Medical Reviewer is responsible for knowing local, US and FDA regulations and guidelines and is expected to provide appropriate feedback in a timely manner. The medical and promotional materials to be reviewed may range the relevant therapeutic areas, including the MorphoSys hematology-oncology portfolio.
The AD/Medical Reviewer will also support the planning and implementation of  the Medical Affairs strategy for the relevant therapeutic areas including medical education, congress activities, and seek and collect insights on local care management landscape ( eg: consolidated field medical insights, competitive intelligence and industry reports and guidelines)
  • Acts as subject matter expert for the relevant therapeutic areas and responsible for review of both medical and promotional materials as an integral part of the LMR Review Committee
  • Data dissemination –strategically supports the publication plan in collaboration with the global scientific communication & publication team
  • Execute key medical data review activities and support creation of new medical materials
  • Support ongoing training of field medical team (MSL), and others as assigned e.g. help with drafting/updating of the medical slide decks and help with training activities for the MSLs 
  • Support the management of a budget for medical affairs strategy for incorporation into the overall study budget
  • Conduct data trend analysis in support of data quality and integrity (includes protocol compliance and targeted review of patient data)
  •  Ensure timely follow-up and resolution of quality and compliance issues
  • Continuously look for opportunities to improve efficiency of tasks and quality of deliverables
  •  Maintain strong internal and external stakeholder relationships
  • Special Projects: Participates in a variety of medical team quality improvement efforts as necessary
  • Performs other related duties as assigned or requested by the Director, Medical Affairs, Vice President, Medical Affairs

Job Qualifications, Experience & Skills

  • Advanced degree is required (e.g. MD, PhD, PharmD, DNP)
  •  Medical Affairs experience within the pharmaceutical industry, 2-3+ years in similar position, in the respective therapeutic areas or similar experience
  • Experience in oncology or hematology-oncology preferred
  • Demonstrates ability to work in a cross-business/cross-functional team and collaborating and solution building
  • Experience with review committee procedures and policies
  • Demonstrated ability to work effectively in matrix teams
  • Demonstrated track record of developing self to drive and enhance performance
  • Proven ability to manage multiple tasks, set priorities and meet deadlines
Health & Safety
  • Full vaccination against COVID 19 is a requirement for this position.
Culture & Benefits
As a full time employee of MorphoSys US Inc., you will receive a comprehensive benefits package consisting of medical and dental, vision, life, disability and more.  We offer a competitive PTO and holiday schedule – giving you the time you need to recharge, along with a 401k retirement plan which allows you the opportunity to save for your future with an employer matching program.  Our culture is a collaborative work environment and we believe the unique contributions each of us brings drives our success. 
 

EEOC Statement

MorphoSys US Inc. is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices.  We are committed to creating a diverse work environment with non-discrimination for all employees and qualified applicants without regard to race, color, religion, national origin, sex, protected veteran status or disability.