Senior Nonclinical Writer (Remote Colombia)
Are you looking to join a company where your contributions truly matter and where youll be part of a supportive innovative teamMMS is aaward-winning data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization recognized for our exceptional culture and industry best employee retention support the pharmaceutical biotech and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
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This person will participate in the development writing and management of highly technical nonclinical documents. This is a full-time remote position.
- Strong experience with development and writing of nonclinical documents (eg Module 2.4 and 2.6 eCTD submission documents1stEditionInvestigators Brochure IB Nonclinical Study Reports Meeting Requests Briefing Documents RTQs).
- Lead projects independently with minimal oversight lead the writing (structure content and messaging) of nonclinicalsubmissiondocumentsfor INDs/CTAs/NDAs/BLAs/MAAs ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity.
- Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports in vivo and in vitro nonclinical data.
- Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents.
- Interpret and analyze applicable pharmacokinetics pharmacology and toxicology data (eg Prism files bioanalytical reports clinical pathology reports PK/TK evaluation reports).
- Collaborate with cross-functional teams such as project management safety efficacy biostats regulatory operations and CMC.
- Demonstrated ability to lead others to complete complex projects.
- Ability to complete documents according to sponsors format processes and according to regulatory guidelines.
- Ability to effectively operate in an environment that requires negotiation persuasion collaboration and analytical judgment.
- Organizational expert within the nonclinical subject area.
- Excellent written/oral communication and strong time and project management skills.
- Ability to attend regular team meetings lead client meeting and CRMs.
- Ability to work in various client systems (eg SharePoint Veeva RIM PleaseReview EndNote) templates and toolbars.
- Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg ICH FDA and EMA regulations and guidelines GLP GCP GMP and GDP).
- BS in pharmacology toxicology biology or chemistry or related field with industry experience within regulatory writing regulatory affairs laboratory sciences quality assurance/control.
- Knowledge of GLP ICH guidelines and applicable regulatory requirements.
- 5years 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 & the drug development process.
Required Experience:
Senior IC
Employment Type : Full-Time
Experience: years
Vacancy: 1