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Medical Affairs Operations Manager

Kelly Services

Princeton, NJ
Job Code:
  • Business Development/Operations
  • Healthcare
  • Medical Affairs
  • Project Management
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Job Details

Job Title Medical Affairs Operations Manager

Jobid US33MXGR_BH1416089

Location: Princeton, NJ, 08542, USA

Description Kelly Services is seeking candidates for a Medical Affairs Operations Manager opportunity in Princeton, NJ. This is a one year assignment. In collaboration with the Associate Director Medical Affairs Operations, the Operations Manager provides operational and logistical support in executing US Medical Affairs strategic initiatives with a focus on the development and execution of accurate program operational plans, timelines and budgets to ensure the successful completion of deliverables including processes related to the conduct of Phase IV clinical trials/Non-Interventional Studies (NIS)/IITs. Ideal candidates with have in-depth experience in operations support of Phase IV clinical trials/non-interventional studies (NIS) and IITs as well as strong contract management experience.

Major Accountabilities

• Support the preparation, review process and finalization of contracts and related documents with third parties related to the US Medical Affairs strategic initiatives

• Carry out operational aspects of communication plans (e.g. planning for advisory boards, steering committee meetings, medical society presence, and abstracts and publications), as appropriate and required.

• Operational support for Phase IV clinical trials/Non-Interventional/IIT studies programs/BD&L projects: protocol development and conduct of clinical studies in adherence to SOPs & standards and government/industry regulations, management of contract research organizations

• Liaise with other departments (e.g. Legal, Compliance, Finance, Procurement/Sourcing, Disease Teams, Global Medical Affairs, etc.).

• Support the documentation and reporting for transparency reporting (Sunshine) for payments to Health Care Professionals in connection with US Medical Affairs programs/activities and Phase IV/NIS/IIT studies

• Foster effective and compliant working relationships and collaboration between Customer and key external stakeholders

• Contribute to on-boarding, training and mentoring of associates

• Collaborate with colleagues within Medical Affairs and from other departments to maximize efficiencies, share and apply best practices

• Makes decisions independently

• Internal and external interaction mainly requires interpretation of complex information

• Adhere to timelines and deadlines

• Effective communicate with management, customers and colleagues

• Complete assigned job tasks and responsibilities in an efficient manner


• BA/BS Degree

• Successful professional with 3-6 years of relevant pharmaceutical experience, preferably within a matrix organization

• Contract management experience

• Project management experience

• Strong experience in clinical trial/project resourcing, methodology, processes and operations

• Prior experience in Phase IV and NIS clinical research involving biologic compounds

• Demonstrated entrepreneurial behavior and problem-solving skills

• Previous experience in presenting scientific data both verbal and written

• Experience having effective interactions with appropriate levels of the organization and with an external audience

• Learning agility

• Knowledge of the scientific and clinical research techniques of assigned area

• Knowledge of GCP and regulatory requirements

• Ability to prioritize, stay organized and meet deadlines under pressure or time constraints and to manage multiple projects in a fast paced environment

• Ability to balance excellent customer service skills with strict compliance requirements

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

Perks of being a Kelly employee:

• Weekly electronic pay

• Access to more than 3,000 online training courses though Kelly Learning center

• Group rate insurance options available immediate upon hire*

• Service bonus plan and holiday pay*

• Online application system

• Never an applicant fee

*perks to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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