MMS
We are a global, data‑focused clinical research organization that prides itself on an inclusive and collaborative culture. Our focus on scientific excellence drives innovation across the pharmaceutical, biotech, and medical device industries.
Roles and Responsibilities
Develop, write, and manage highly technical nonclinical documents, including Module 2.4 and 2.6 eCTD submissions, Investigator’s Brochures, Nonclinical Study Reports, Meeting Requests, Briefing Documents, and RTQs.
Lead projects independently with minimal oversight, ensuring that content aligns with current regulatory guidelines and meets scientific integrity.
Author documents based on highly technical sources such as GLP and non‑GLP study reports, in‑vivo and in‑vitro data, and pharmacokinetic, pharmacology, and toxicology reports.
Create a mapping plan for the placement of nonclinical studies within Module 2.4 and 2.6 eCTD submission documents.
Interpret and analyze applicable data and collaborate with cross‑functional teams, including project management, safety, efficacy, biostats, regulatory operations, and CMC.
Lead and mentor team members to complete complex projects, maintaining sponsor format and regulatory guidance compliance.
Operate effectively in environments that require negotiation, persuasion, collaboration, and analytical judgment.
Employ strong written and oral communication skills, project management, and time‑management abilities.
Attend regular team meetings and lead client meetings and CRM sessions.
Work with various client systems such as SharePoint, Veeva RIM, PleaseReview, EndNote, templates, and toolbars.
Maintain an organizational understanding of the nonclinical subject area and regulatory guidances (ICH, FDA, EMA, GLP, GCP, GMP, GDP).
Requirements
BS+ in pharmacology, toxicology, biology, chemistry, or a related field with relevant industry experience in regulatory writing, regulatory affairs, laboratory sciences, or quality assurance/control.
Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
Minimum 2+ years of pharmaceutical regulatory nonclinical writing experience.
Strong writing and analytical skills.
Proficiency with MS Office applications.
Hands‑on experience with clinical trial and pharmaceutical development preferred.
Basic understanding of CROs and scientific & nonclinical data terminology and the drug development process.
Seniority level: Entry level
Employment type: Full-time
Job function: Marketing, Public Relations, and Writing/Editing
Industry: Pharmaceutical Manufacturing
Referrals may double your chances of being interviewed.
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Roles and Responsibilities
Develop, write, and manage highly technical nonclinical documents, including Module 2.4 and 2.6 eCTD submissions, Investigator’s Brochures, Nonclinical Study Reports, Meeting Requests, Briefing Documents, and RTQs.
Lead projects independently with minimal oversight, ensuring that content aligns with current regulatory guidelines and meets scientific integrity.
Author documents based on highly technical sources such as GLP and non‑GLP study reports, in‑vivo and in‑vitro data, and pharmacokinetic, pharmacology, and toxicology reports.
Create a mapping plan for the placement of nonclinical studies within Module 2.4 and 2.6 eCTD submission documents.
Interpret and analyze applicable data and collaborate with cross‑functional teams, including project management, safety, efficacy, biostats, regulatory operations, and CMC.
Lead and mentor team members to complete complex projects, maintaining sponsor format and regulatory guidance compliance.
Operate effectively in environments that require negotiation, persuasion, collaboration, and analytical judgment.
Employ strong written and oral communication skills, project management, and time‑management abilities.
Attend regular team meetings and lead client meetings and CRM sessions.
Work with various client systems such as SharePoint, Veeva RIM, PleaseReview, EndNote, templates, and toolbars.
Maintain an organizational understanding of the nonclinical subject area and regulatory guidances (ICH, FDA, EMA, GLP, GCP, GMP, GDP).
Requirements
BS+ in pharmacology, toxicology, biology, chemistry, or a related field with relevant industry experience in regulatory writing, regulatory affairs, laboratory sciences, or quality assurance/control.
Knowledge of GLP, ICH guidelines, and applicable regulatory requirements.
Minimum 2+ years of pharmaceutical regulatory nonclinical writing experience.
Strong writing and analytical skills.
Proficiency with MS Office applications.
Hands‑on experience with clinical trial and pharmaceutical development preferred.
Basic understanding of CROs and scientific & nonclinical data terminology and the drug development process.
Seniority level: Entry level
Employment type: Full-time
Job function: Marketing, Public Relations, and Writing/Editing
Industry: Pharmaceutical Manufacturing
Referrals may double your chances of being interviewed.
#J-18808-Ljbffr