Our client is seeking a Regulatory Affairs SOP Writer (Contract-Remote Position)!
Our client specializes in providing services for auditing on a global scale in the medical industry. The company holds an excellent employee-retention rate and offers competitive salaries and bonus structures. And this position allows for expansion and upward mobility in the future.
Specific Responsibilities:
The company is looking for a talented SOP/Technical Writer with experience in Regulatory Affairs in the Life Sciences industry. The candidate will be a passionate new team member who can take the initiative, create and function successfully in a collaborative environment, and solve problems to drive effective value-added results for our clients.
- The SOP/Technical Writer is responsible for working with Regulatory Affairs Topic Owners and Subject Matter Experts (SMEs) to prepare new or make changes to existing SOPs required to support the implementation of a new Regulatory Information Management (RIM) System.
- Incorporate changes identified as a part of the Change Impact Analysis conducted by Organizational Readiness and Deployment (ORD), to-be process diagrams developed by Service Delivery, and input from topic area SMEs
- Work with topic area SMEs to develop process models (Visio diagrams)
- Translate process maps or other process representations into written procedures
- Coordinate reviews by Topic Owners, SMEs, and other key stakeholders as well as consolidate comments and resolve conflicts collaboratively
- Work with Development Quality Management to ensure appropriate document standards criteria are met
- Ensure terminology and writing style is consistent across documents
- Conduct a Knowledge Transfer to the Training organization for use in conducting training
- Prepare status reports for the Client and Mazars leadership team
Qualifications:
- Bachelor’s Degree in science or related field with a minimum of 5 years of relevant experience in Regulatory Affairs
- Minimum of 5 years in technical and/or business process writing in the Pharmaceutical industry
- In-depth knowledge of ICH GCP, FDA, and EMA regulations and guidance
- Experience authoring and revising GxP documentation
- Excellent technical writing skills and command of the English language.
- Advanced proficiency in MS Word (including using styles and creating controlled forms) and MS Visio
- Working knowledge of GxP document control systems and document review tools
- Experience with Regulatory Information Management (RIM) Systems (ArisGlobal preferred)
- Ability to manage and coordinate multiple projects and assignments in a demanding, cross-functional, fast-paced environment with changing priorities
- Technical writing certification preferred
- Must be self-motivated and can effectively work with minimal supervision; must also be able to work as part of a cross functional team.
Qualified Candidates Please Send us your CV
Biotech Partners is one of the leading Life Sciences recruiting companies throughout the United States, placing qualified candidates with world-renowned organizations for over twelve years. Our recruiting consultants are experts in their markets and provide industry insights and interview coaching to their candidates throughout the engagement process.
