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, project and program management, and early phase clinical trial 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 employees’ career development, and it works closely with each employee to map out goals, assess performance, and identify areas for growth. IMPACT employees are also encouraged 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

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.
  • Mentoring and training of entry-level medical writers on internal QC processes.
  • 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 our first full-time QC Specialist to join our new 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 Writer

The primary responsibilities of a Medical Writer 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. These types of scientific and regulatory documents 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). A Medical Writer may also assume project management responsibilities (eg, Sponsor-facing correspondences and internal resourcing needs).

Candidates must have either an advanced degree (eg, Ph.D., Pharm.D., M.D.) in life or health sciences and at least 1 year 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 at least 3 years of medical writing experience in a pharmaceutical company, CRO, or comparable environment. 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

The primary responsibilities of a Senior Medical Writer 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 sections of Investigational New Drug Applications (INDs) 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). A Senior Medical Writer may assume project leadership positions (eg, managing 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, Ph.D. or M.D.) in life or health science and at least 5 years of medical writing experience in a pharmaceutical company, contract research organization (CRO), or comparable environment, or an undergraduate degree in life or health science and at least 10 years of medical writing experience in a pharmaceutical company, CRO, or comparable environment. 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.

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.