Experience. Integrity. IMPACT.
Experience. Integrity. IMPACT.

Why Choose IMPACT

Careers

IMPACT is a CRO that specializes in medical writing and quality control, drug development consulting, regulatory affairs, regulatory operations, and project and program management.

Our Culture

Our company culture is consistent with our core values of quality, integrity, flexibility, and responsiveness.  At IMPACT, we encourage open, two-way communication throughout the company and provide a supportive and encouraging environment that allows our employees to achieve their greatest potential.

Our employees describe the work environment at IMPACT as positive, stimulating, collaborative, and fast-paced, yet flexible enough to maintain a healthy balance with their personal lives.  In recent years, the majority of hires at IMPACT have been through employee referrals, which is testament to how much our employees feel valued and respected and love being part of our team.

At IMPACT, we realize the vital role a positive work/life balance plays in establishing a rewarding, productive, and long-term career.  As a result, a flexible, family-friendly work environment is a key element of our culture and is one of a number of reasons people want to work (and stay) here!

Career Development

Each employee receives ample mentoring and coaching at IMPACT, which is a reflection of our highly collaborative culture. We are deeply vested in the unique talents, skills, and interests of our employees, and we strive to provide them with top-notch training.

Our management team is committed to each employee’s career development, and it works closely with each employee to map out goals, assess performance, and identify areas for growth. IMPACT also encourages employees to obtain relevant, recognized professional certifications by providing assistance for continuing education and supporting attendance at local and national seminars and conferences.

Employee Benefits

In addition to a competitive salary, IMPACT offers a wide array of benefits that reflect the strength of our commitment to our employees including medical and dental insurance, vision care, short- and long-term disability, life insurance, and a 401K plan with competitive company matches.

In addition, employees are provided a generous amount of paid time off as well as 4 hours per month to participate in volunteer activities as part of our Making an IMPACT community service initiative.

Want to take your career to new heights? Consider joining the IMPACT team.

IMPACTR

Open Positions

Human Resources (HR) Manager

The HR Manager at IMPACT will have broad responsibility for all HR functions, including, but not limited to, employee relations, benefits administration, new hire onboarding, and recruiting/talent acquisition, with an emphasis on talent acquisition and employee relations. This is a highly visible role that requires the highest level of professionalism and sensitivity.  The successful candidate will have experience tackling a wide variety of human resources tasks and providing support to individuals at all levels of the organization.

Responsibilities:

  • Manage full life-cycle recruiting process from posting to offer, including defining hiring manager expectations, scheduling interviews, and building relationships with candidates throughout the recruitment process
  • Conduct onboarding process for new employees, including orientation and all necessary paperwork and benefits enrollments
  • Represent company at recruiting functions, such as job fairs, career days, etc.
  • Coordinate with approved outside recruitment sources, when needed
  • Perform employee relations function across the organization to assist employees and managers in resolving issues and grievances. Provide counseling regarding personnel and job related conflicts, engage in problem solving and dispute resolution, and assist managers in remediating employee performance issues.  Conduct employee related investigations, as necessary.
  • Ensure company policies are administered fairly and consistently throughout the organization
  • Effectively communicate and execute necessary changes to personnel policies and procedures
  • Maintain the employee handbook
  • Perform benefits administration, including management of open enrollment periods and annual renewals, change reporting, approving invoices for payment, and communicating benefits information to employees
  • Ensure compliance with federal, state, and local employment and benefits laws and regulations

Qualifications:

  • Bachelor’s degree in human resources, business, or related field or equivalent years of experience
  • 5+ years of work experience in human resources
  • Proven record of appropriate management of sensitive and confidential information
  • Certifications for Human Resource Professionals (PHR, SPHR) strongly preferred
  • Excellent communication and interpersonal skills
  • Strong problem-solving skills
  • Demonstrated ability to employ sound judgment and initiative in order to accomplish job duties in a satisfactory and timely manner
  • Ability to prioritize and organize effectively
  • Ability to multi-task and to work independently, with minimal supervision

This is an exciting time for IMPACT, as we are growing and expanding our infrastructure. The ideal candidate will have previous experience in a contract research organization, broad human resources knowledge, and a willingness to work with IMPACT’s management team to ensure the maintenance of a robust and reliable human resources system.
This is an office-based position located in Research Triangle Park, NC, reporting to the SVP, Business Operations & CFO.

Regulatory Operations Publisher/Senior Publisher

The Regulatory Operations Publisher is responsible for the timely preparation of submission ready components and publishing of global regulatory submissions. The candidate must demonstrate the ability to work independently and manage multiple priorities.

Responsibilities:

  • Provides MS Word and PDF document formatting support to ensure consistency with company and health authority submission ready standards
  • Reviews documents and liaises with contributors to address deficiencies and provide guidance related to requirements for electronic submission
  • Compiles and publishes high-quality electronic regulatory submissions in eCTD format utilizing publishing software
  • Acts as primary contact for the assembly and transmittal of regulatory submissions
  • Conducts and/or participates in the final review of publish-ready submissions to ensure compliance to regulatory standards and requirements for electronic submissions
  • Participates on submission working teams or other Regulatory Operations teams related to submission planning
  • Collaborates with internal team members to assure standard practices and quality submission deliverables

Qualifications:

  • Bachelor’s Degree required, or equivalent relevant work experience
  • Minimum of 1-3 years of experience working within the pharmaceutical industry, preferably in a publisher role (biotech, pharmaceutical or clinical research organization)
  • Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools
  • Ability to multi-task, pay close attention to detail, and follow projects through to completion.
  • Knowledge of the drug development process.
  • Knowledge of global regulatory requirements with a strong focus on US, EU, ICH requirements.
  • Excellent communication and interpersonal skills

This is an office-based position located in Research Triangle Park, NC, reporting to the Director, Regulatory Operations.

IT Manager

The primary responsibility of the IT Manager at IMPACT is, but is not limited to, working across operations to manage networks and information technology systems for the company. These efforts will vary broadly—from maintenance of information resource integrity to network security, software licensing, and ensuring the health of hardware throughout the company. The successful candidate will have experience tackling various hardware and software problems, will be comfortable providing technology solutions to employees, and will have the knowledge necessary to work closely with third party providers to adopt new technologies and to make effective use of existing ones.

Qualified candidates will have prior experience working with information technology and an understanding of the latest technology trends.

Responsibilities:

  • Setup, maintain, and troubleshoot network, including LAN/WAN/Switching, wireless, & VPN
  • Ensure security of data, network access, and backup systems
  • Respond in a timely manner to network issues and service requests
  • Setup network accounts for new users
  • Provision and troubleshoot all user hardware, including laptops, desktops and tablets, in a Windows environment
  • Manage computers and devices, ensuring device inventory, security, and timely updates
  • Repair and replace computers or network equipment, as necessary
  • Administer end-user accounts and licensing across a variety of applications, including the full suite of Microsoft Office and Adobe products
  • Provide technical support to all company end users
  • Manage and maintain printers and related software
  • Manage phone system, including user provisioning and VoIP configuration and troubleshooting
  • Act as main point of contact for internet service provider & all technology partners
  • Support users in use of AV and video conferencing equipment
  • Identify opportunities for improvement in systems and processes
  • Assess and evaluate new technologies
  • Act as point of contact for all technology-related issues. Occasional night or weekend work may be required.

Qualifications:

  • Bachelor’s degree in computer science, information technology, or equivalent years of experience
  • 4+ years of work experience in IT, preferably in a contract research organization, pharmaceutical, biotechnology, or other regulated setting
  • Knowledge of current technology trends
  • Proficient in managing Windows servers, Windows operating systems, routers and switches, and various types of firewalls
  • Experience with Office 365 a plus
  • Current knowledge of security protocols and known threats
  • Excellent communication and interpersonal skills
  • Strong Problem-solving skills
  • Highly detail-oriented, accurate, and organized
  • Ability to multi-task and to work independently, with minimal supervision
  • Industry certifications are a plus

This is an exciting time for IMPACT, as we are growing and expanding our infrastructure. The ideal candidate will have previous experience in a CRO environment, broad information technology knowledge, and a willingness to work with the hiring manager to ensure the maintenance of a robust and reliable IT infrastructure.

This is an office-based position located in Research Triangle Park, NC, reporting to the SVP, Business Operations & CFO.

Quality Control Specialist – Regulatory Medical Writing

The primary responsibilities of a Quality Control (QC) Specialist at IMPACT include, but are not limited to, document QC reviews of assigned regulatory medical writing deliverables with moderate supervision to ensure accuracy of data with source materials and consistency with customer and/or regulatory submission standards. These types of deliverables can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of Investigational New Drug (IND) Applications and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (ie, integrated summaries of safety and efficacy, product labeling, and summaries and overviews of nonclinical and clinical information). Documents undergoing QC vary widely in terms of therapeutic areas, sponsors, and styles.

Additional duties and responsibilities may include:

  • Keeping the medical writers and managers informed on progress of documents and other project-related information.
  • Managing QC review of multiple-document projects, such as large-scale subject safety narrative projects and INDs/NDAs/BLAs.
  • Performing other duties, as assigned, such as population of in-text data tables.

Candidates must have a Bachelor’s, Master’s, or an advanced degree (eg, Ph.D., Pharm.D., M.D.) in life or health sciences, English/journalism, or extensive document editing/QC review or equivalent related education and experience. A minimum of 2 years of experience working in a life science or clinical research environment, preferably in a contract research organization (CRO), pharmaceutical, or biotechnology setting is preferred. Medical/ technical writing experience and/or experience in a QC function is preferred. Board of Editors in the Life Sciences (BELS) certification also preferred, but not required. Excellent command of the English language (grammar, spelling, and punctuation), attention to detail, and ability to function collaboratively in a team environment are mandatory. Strong proficiency in many software applications, particularly the Microsoft Office suite (Word, Outlook, and Excel) and Adobe Acrobat also required.

This is an exciting time for IMPACT, as we are looking for a full-time QC Specialist to join our growing QC department. The ideal candidate will have previous experience in a CRO environment coordinating QC work with internal resources and contractors and will be willing to work with the hiring manager to establish processes in this new and growing department.

This is an office-based position located in Research Triangle Park, NC; however, IMPACT has a flexible work schedule that allows employees to periodically work from home.

Medical Writing Fellow

The primary responsibilities of a Medical Writing Fellow at IMPACT include, but are not limited to, preparing scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics. This full-time fellowship program runs for approximately 9 months of each year and will host 2 to 4 fellows per class. Accepted fellows will receive a competitive salary and our standard benefit package during this fellowship. For a full description of the Medical Writing Fellowship Program and fellow responsibilities, click here. Applications to this program are accepted year-round and should be submitted to rovercash@impactpharma.com.

Candidates must have either an advanced degree (eg, PhD, PharmD, MD) in life or health sciences (no medical writing experience is required); candidates with undergraduate or master’s degree in life or health sciences who have significant writing experience may also be considered. This is an office-based position located in Research Triangle Park, NC; however, IMPACT has a flexible work schedule that allows employees to periodically work from home.

Senior Medical Writer/Senior Clinical Research Scientist

The primary responsibilities of a Senior Medical Writer/Senior Clinical Research Scientist at IMPACT include, but are not limited to, preparing (under minimal supervision) scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics. These types of scientific and regulatory documents can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and the clinical sections of Investigational New Drug (IND) Applications and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (eg, integrated summaries of safety and efficacy, product labeling, and summaries and overviews of nonclinical and clinical information). A Senior Medical Writer/Senior Clinical Research Scientist may assume project leadership positions (eg, managing IND/NDA/BLA submissions) and may coordinate the activities of other Medical Writers and/or IMPACT staff.

This position is located in Research Triangle Park, NC. Candidates must have either an advanced degree (eg, PhD, PharmD, MD) in life or health sciences and approximately 3 years of medical writing experience in a pharmaceutical company, contract research organization (CRO), or comparable environment, or an undergraduate degree in life or health sciences and approximately 5 years of medical writing experience in a pharmaceutical company, CRO, or comparable environment. This is proposed to be an office based position located in Research Triangle Park (RTP), NC. However, IMPACT has a flexible work schedule that allows employees to periodically work from home (if the candidate is located in the RTP area), and IMPACT would consider a fully remotely-located employee depending on the strength and experience of the candidate.

If you would like to be considered for one of these positions, please submit your CV and a cover letter to careers@impactpharma.com. In your cover letter, please tell us why you think you would be a good fit for IMPACT. CVs without cover letters will not be reviewed.


IMPACT is an Equal Employment / Affirmative Action employer m/f/d/v EO 13201.