Careers

At Opus Regulatory, we take pride in being a company who hires exceptional people who exemplify high standards and a passion to create significant benefits for our clients and employees. If you are interested in joining a fast-paced entrepreneurial team, where every person matters, submit your resume to hr@opusregulatory.com.  

 

Human Resource Manager

Founded in 1994, Opus Regulatory is an innovative consulting firm serving biopharmaceutical companies throughout the US.  Due to unprecedented growth, we are currently seeking an experienced and motivated Human Resource Manager for our company headquarters in Cambridge, MA.

This individual will be responsible for supporting HR administration, company benefits, compliance, HRIS, payroll, performance management and training, employee support, and recruitment. The ideal candidate is a self-starter who exemplifies high quality standards, is passionate about their work, and thrives in a fast-paced environment.

HR Administration:

  • New Employee Onboarding and Orientation
  • Maintain employee personnel files
  • Assist with HR projects as necessary
  • Oversee Payroll administration

Benefits Administration:

  • Monitors employee eligibility for benefits plans
  • Review benefits with employees and process enrollment, cancellation or changes.
  • Organize and manage annual enrollments, communications and election process
  • Maintain and distribute list of new and cancelled employees under each benefit plan.
  • Verify benefit billing accuracy and processes for payment
  • Administers COBRA for group health plans
  • Will assist with all leave management (FMLA, LTD, STD, etc.)

Compliance:

  • Ensures compliance with USCIS Form I-9 Employment Eligibility Verification
  • Maintain and processes all unemployment notices of entitlement and potential charges in a timely, efficient manner.
  • Attends unemployment hearings when necessary.

HRIS:

  • Own the HRIS function, maintaining and updating the system
  • Upload accurate and timely information
  • Conduct quarterly audits ensuring that all employee changes in the HRIS system are transferred to Payroll


Performance Management & Training:

  • Monitors, tracks and distributes tardiness, absenteeism and PTO reports
  • Manages and tracks all trainings and certifications
  • Provide and develop training for employees when needed

Employee Support/Relations:

  • Develop and implement new hire orientation
  • Fields employee questions.
  • Help develop and plan employee activities/parties
  • Maintain and coordinate employee recognition programs

Administrative and Ad Hoc Projects

  • Manage travel arrangements and expense reimbursements
  • Managing payroll tax registration, registered agent services and state openings/dissolutions

 
Recruiting:

  • Sourcing candidates leveraging social media platforms, employee referrals, and networking
  • Update candidate records via company CRM System to maintain current accurate information
  • Following up with paperwork
  • Developing and posting job descriptions on multiple portals and websites
  • Phone screening candidates, coordinating and conducting in-person interviews

Qualifications:

  • Bachelor’s Degree
  • 3-5 years of experience in Human Resource Management
  • Exceptional proficiency in MSOffice and a strong background in database/CRM systems and social media applications
  • Strong benefits administration experience
  • Must have strong compliance experience (FMLA, ADA, ACA, etc.)
  • Familiarity with HRIS systems
  • Working knowledge of payroll laws, payroll processing, state/federal taxes
  • Experience working in a startup/entrepreneurial culture, adaptable and willing to wear multiple hats
  • Personable Self-starter with the ability to collaborate with team members
  • Excellent organizational and multitasking skills with a detail orientation and a “no task is too big or small” attitude
  • Aptitude for learning industry technology with a genuine interest in the Pharmaceutical Industry

Opus Regulatory is committed to offering a comprehensive and competitive total rewards package to recruit and retain talented professionals. Our benefits program includes medical, dental and vision insurance in addition to 401(k) and paid time off.

For consideration, please submit cover letter and resume to humanresources@opusregulatory.com

PLEASE NO PHONE CALLS OR THIRD-PARTY RECRUITMENT AGENCIES

 

Regulatory Affairs Consultants

FTE and hourly Consulting opportunities exist for Senior Manager to Executive Director levels within all regulatory affairs functional areas including:

  • Advertising / Promotion
  • Labeling
  • Regulatory Strategy

Most roles offer a significant home-based schedule.
Requirements: 4+ year's pharmaceutical regulatory affairs experience, advanced degree/science background preferred.

Consulting opportunities change frequently. For specific details contact Dave Sawyer at dave.sawyer@opusregulatory.com

 

Account Executives

Due to sustained company growth, we are seeking Account Executives to develop new business opportunities at prospective and existing clients.

Responsibilities include:

  • Research new business leads.
  • Diligently conduct client company and project pre-qualification
  • Develop new clients through intensive networking, prospecting, client meetings and attending industry trade shows and conferences.
  • Negotiate business contracts and close new projects with client decision makers
  • Expand existing client services by developing additional RA functional area groups.
  • Work with a strong sense of customer satisfaction.
  • Research and qualify existing and new Opus Regulatory consultants
  • Establish and maintain a positive working relationship with all colleagues, consultants and clients

 

Required attributes: 

  • Excellent written and verbal communication skills
  • Highly motivated and driven
  • Strong work ethic
  • An outgoing personality and positive outlook
  • Keen attention to detail
  • Individuals interested in working within a small company, entrepreneurial environment

Required background:

  • BS/BA degree. Medical/Scientific area of focus preferred but not required.
  • 2+ years' experience working within a life science industry (e.g. biotechnology, pharmaceutical, medical device).
  • 1+ years' experience within Regulatory Affairs or related specialty (e.g. clinical research, medical affairs, QA).
  • Knowledge of the pharmaceutical industry, the drug development process, regulatory submissions (IND, NDA, etc.), and post-market compliance.
  • Prior sales/marketing experience desirable but not required.

 

Opus Regulatory, Inc. offers the benefits of both a dynamic entrepreneurial environment and financial stability.  We provide hands-on training, a competitive starting compensation plan, high income earning potential, and a comprehensive benefits plan (see below). 

Please respond with a resume and cover letter to:
Alison Fox at Alison.fox@opusregulatory.com
or Dave Sawyer at dave.sawyer@opusregulatory.com

Equal Employment Opportunity Policy

Opus is committed, in accordance with applicable law, to a policy of nondiscrimination and equal opportunity for all employees and qualified applicants. It will not discriminate on the basis of race, color, religious creed, national origin, ancestry, sex, marital status, sexual orientation, age, disability, or as a disabled Veteran, or any other basis protected by law.
While Management is responsible for the development of plans, programs, and controls to ensure that our policy is carried out, we expect all employees to provide individual and collective support for equal employment Opportunity at Opus Regulatory.

Opus Regulatory will provide reasonable accommodations, in accordance with the regulations of the Americans with Disabilities Act, and State law.

 

Our Benefits

Opus Regulatory is committed to offering a comprehensive and competitive total rewards package to recruit and retain talented professionals. Our benefits program offers a broad array of plans to support our workforce physically, financially, and personally. We currently offer the following benefits:

Health & Wellness

  • Medical
  • Dental
  • Vision

Financial

  • 401k retirement plan
  • Life insurance
  • Short-term and long-term disability

Quality of Life

  • Paid vacation
  • Paid holidays
  • Paid Sick days
  • Paid personal days
  • Paid jury days
  • Most Regulatory Consultant positions offer significant home-based arrangements

This summary is an overview of benefits to prospective employees. More extensive information is provided to new employees upon hire.  Paid time off, paid holidays and paid personal days are offered to full time employees.

Current Opportunities

Human Resource Manager

Regulatory Affairs Consultants

Account Executives