Medical Affairs Management


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Medical Affairs Management

Whippany, New Jersey Contract Job ID: 2210152696
Estimated Duration: 7 months

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Description
PDS Tech, Inc. is seeking a Medical Affairs Management.

Department Description:
  • Operational Excellence and Project Management in Global Medical Affairs (GMA), Oncology SBU is a global function which partners and collaborates with the MA Teams and Key Stakeholders (internal and external) to assist in achieving short and long term strategic goals while adhering to “LIFE” values (leadership, integrity, flexibility, efficiency).
Position Summary:
  • The Senior Contract Operations Excellence & PM Manager position is accountable for compliant and high quality management of GMA company-sponsored studies (both non and interventional), Investigator Initiated Research (IIR) and Investigator-Sponsored Collaborative Studies (ISCS) data acquisition projects, and Expanded Access Programs (EAPs)
Duties and Responsibilities:
  • Lead all aspects of clinical studies from planning to execution. Assigned studies include interventional, non-interventional and data acquisitions within Global Medical Affairs Oncology SBU.
  • Overall accountable for study management of assigned studies, serve as primary contact for CRO. Lead and manage Bayer multi-disciplinary cross functional team in all aspects of studies activities including but not limited to site start up, CRO/vendor selection and management, study-specific timelines and study execution.
  • Coordinate for fair market value assessment of study budgets; initiate and manage contracting process. Liaise with appropriate Bayer internal protocol review committees to ensure timely review, response and finalization of the protocol and protocol amendment.
  • IIR and/or ISCS data acquisition projects. Responsibilities include chair conference calls, coordinate between Bayer team and IIR-sponsors on activities such as data review, query resolution and independent review of imaging scans, when applicable. Develop and manage overall project timelines.
  • Support GMA Medical Leads on overall delivery of the data generated from Oncology Non-Interventional Studies (NIS). Responsibilities include, but not limited to, monitor country/site selection and activation process, contribute in CRF design and review, study budget management, support Medical Leads on clinical data consistency review to ensure that data issues raised during medical and DM data review are adequately queried and resolved.
  • Manage study drug forecasting. Liaise with Clinical Supplies Management to ensure drug supply planning, labeling and distribution are executed timely and within applicable country and regional guidelines.
  • Assist and/or lead in executing Expanded Access Programs within Oncology MA. Responsibilities include collaborate with country affiliates and Medical Experts as appropriate to ensure timely alignment and execution of country specific processes including permit license application, commercial product transition plan, and Real World Data (RWD) data generation when applicable.
Qualifications
Education Requirement(s):
  • Bachelor’s degree required; life science preferred
  • Masters in Science or Business Administration - preferred
Skill & Competency Requirements:
  • Extensive (7+ years) study management experience involving Phases 2 & 3 studies from planning through regulatory submission; regulatory submission experience a plus
  • Understanding of the connection between protocol endpoints, study design, CRF design and data collection; clinical science backyard a plus
  • At least 5 years Oncology experience (can be outside of industry)
  • Strong written, organizational, and computer (e.g. Excel, power point) skills
  • Excellent interpersonal and communication skills as candidate will interact with Bayer cross functional team members as well as liaise with external academic networks and cooperative groups from all over the global
More Details

PDS Tech, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Founded in 1977, PDS Tech, Inc. is one of the nation's premier specialty staffing firms with 31 offices nationwide. We offer a full range of benefits including:

  • Health insurance
  • Paid holidays
  • Weekly payroll
  • Immediate 401(k) eligibility
  • Completion Bonuses
  • Training
  • Please note availability of benefits may vary by position

PDS specializes in Engineering and IT arenas including Aerospace, Defense, Electronics, Telecommunications, Automotive, and Energy just to name a few. Our reputation, track record, and years of continuous growth reflect the commitment to quality that our employees and clients experience first-hand. To find out more about PDS, please visit www.pdstech.com

$$$ PDS pays for referrals! $$$

We pay thousands each month in referral bonuses!
Contact a recruiter for details. To find one near you, take a look at where we are.

If you have questions, please click here to contact us.


PDS Tech, Inc. is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities.
If you need special assistance or an accommodation while seeking employment, please click here or call 1-800-270-4737 to contact us. We will make a determination on your request for reasonable accommodation on a case-by-case basis.

The law requires PDS Tech, Inc. to post a notice describing the Federal laws prohibiting job discrimination. For information regarding your legal rights and protections, please click on the following links: EEO is the Law and EEO is the Law Supplement

PDS Tech, Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. Please see the Pay Transparency Nondiscrimination Provision for more information.

As a Federal Contractor, PDS Tech, Inc. is required to participate in the E-Verify Program to confirm eligibility to work in the United States.
For information please click on the following link: E-Verify