medical writer Remote
Certara
Full Time
Remote
10.56 - 12.04 CAD Today
Job description
Overview:
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Senior Regulatory Writer (SRW) is a major contributor to document authorship for a variety of documents across different service lines. The SRW will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team. Synchrogenix is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals.Responsibilities:
Skills & Abilities:
Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions and regulatory agencies across 62 countries.
Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Senior Regulatory Writer (SRW) is a major contributor to document authorship for a variety of documents across different service lines. The SRW will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery team. Synchrogenix is looking for individuals looking to use their expertise in clinical regulatory writing to lead teams and help clients achieve their goals.
- Lead or participate in a project team which may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer
- Author documents per client specifications, templates, style guides, and other guidance documents
- Author documents per regulatory authority guidelines and requirements
- Act as client advisor, working with all parties to lead development of strategies for organizing and preparing regulatory documents
- Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
- Manage budget for a low complexity project, including all contributors (writers, editors)
- Usher documents through the review process, conduct comment resolutions meetings (CRMs), and successfully lead a project team to consensus
- Maintain collaborative, proactive, and effective communication with both client and internal teams
- Lead or participate in project-related meetings and teleconferences
- Provide coaching to junior staff for study level documents
Education, Experience, Training, and Knowledge:
- Bachelor’s degree
- 3+ years of regulatory writing experience or equivalent experience with clinical related documentation
- Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
- Experience in the development of submission-level documents (does not require functioning as a document lead)
- Experience in the development of clinical documents such as Clinical Study Reports, Investigator Brochures, protocols ISS and/or ISE
Skills & Abilities:
- Intermediate proficiency with Microsoft Word skills (editing tools, creating and modifying tables and inserting figures) and document management techniques
- Strong understanding of the document creation process and of the drug development lifecycle
- Able to synthesize data across multiple data sources and documents to create summary reports
- Ability to conduct/lead a CRM and successfully lead a project team to consensus
- Ability to use logical arguments to persuade others when presenting ideas and suggestions, but also
- respond positively to opposing views voiced by others
- Develops professional relationships with clients as a way to further the business relationship and
- maintain current industry knowledge
- Ability to identify and institutionalize work practices that are most effective in order to ensure
- consistency in performance
About Certara
CEO: William Feehery
Revenue: Unknown / Non-Applicable
Size: 501 to 1000 Employees
Type: Company - Public
Website: http://www.certara.com
Year Founded: 2008
Certara
http://www.certara.com
Princeton, United States
William Feehery
Unknown / Non-Applicable
501 to 1000 Employees
Company - Public
Biotech & Pharmaceuticals
2008
