Medical Affairs Operations Associate
Job
Actalent
Remote
$124,800 Salary, Full-Time
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Job Description
Job Title:
Medical Affairs Operations Associate (Contractor) Job Description The Medical Affairs Operations Associate (Contractor) provides hands-on operational support to the Medical Affairs function, with a primary focus on coordinating Medical, Legal, and Regulatory (MLR) review and providing administrative support for Grants and Sponsorships. This role partners closely with internal stakeholders and external scientific communications agencies to ensure timely, compliant review and execution of Medical Affairs deliverables in a fast-paced, evolving environment. Responsibilities Coordinate end-to-end Medical, Legal, and Regulatory (MLR) review processes to ensure timely and compliant approval of Medical Affairs materials. Serve as a central point of contact between internal reviewers and external scientific communications agencies throughout the MLR review cycle. Manage submissions in the Veeva MedComms platform, including intake, routing, tracking, and follow-up on review status. Support administrative processes for Grants and Sponsorships, including tracking, documentation, and coordination of information and workflows. Help maintain and refine operational processes and tools that support Medical Affairs activities as the organization grows. Assist with implementing and supporting tracking mechanisms for Grants and Sponsorships while a formal platform is in development. Apply understanding of regulatory guidelines and Fair Market Value (FMV) principles to support compliant Medical Affairs operations. Collaborate with cross-functional internal stakeholders to ensure alignment and smooth execution of Medical Affairs deliverables. Contribute to the development and continuous improvement of Medical Affairs operational best practices and procedures. Essential Skills At least 2 years of industry experience in medical affairs or medical operations roles. Demonstrated experience coordinating MLR (Medical, Legal, Regulatory) review processes. Hands-on experience using Veeva MedComms or similar Veeva-based MLR platforms. Experience working within a Medical Affairs department. Understanding of applicable regulatory guidelines relevant to Medical Affairs activities. Knowledge of Fair Market Value (FMV) concepts and their application in Medical Affairs operations. Ability to perform effectively in a fast-paced, evolving environment. Strong coordination, organization, and communication skills to manage multiple stakeholders and deadlines. Additional Skills & Qualifications Grants and Sponsorships experience within Medical Affairs, including administration, tracking, and documentation (preferred). Experience partnering with external scientific communications agencies to manage medical and scientific content review. Experience helping build or refine operational processes in a growing organization. Familiarity with tracking tools and platforms for Grants and Sponsorships, or the ability to quickly learn new systems. Strong attention to detail and a process-oriented mindset to support compliant and efficient operations. Work Environment The role operates in a hybrid work environment with the expectation to be onsite approximately once per week for live, in-person MLR review meetings. Outside of these in-person sessions, the schedule is flexible based on business needs. Work is conducted in close collaboration with internal reviewers and external scientific communications agencies, primarily through the Veeva MedComms MLR platform and related digital tools. The environment is dynamic, fast-paced, and growth-oriented, with opportunities to help shape and improve operational processes, including supporting current Grants and Sponsorships tracking and enabling future implementation of a formal platform. Job Type & Location This is a Contract position based out of Waltham, MA. Pay and Benefits The pay range for this position is $55.00 - $65.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:- Medical, dental & vision
- Critical Illness, Accident, and Hospital
- 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
- Life Insurance (Voluntary Life & AD&D for the employee and dependents)
- Short and long-term disability
- Health Spending Account (HSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Waltham,MA.
San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.Similar remote jobs
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