Human Resources Germany
ARCONDIS is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,
information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are looking for a SOP Writer & Coordinator / Technical Writer (fixed-term (one year) contract):
The SOP/ Technical Writer, supports the SOP creation during the qualification of equipment by collaborating with authors and Subject Matter Experts (SMEs) to revise or create SOPs, Work Instructions, forms, checklists or manuals.
Primary responsibilities include gathering and consolidating input from cross functional stakeholders, developing process maps, reviewing current GxP regulatory requirements (ICH guidelines, FDA CFRs, EMA directives, etc.) company SOPs and developing them into clear and concise procedures.
The SOP/Technical Writer is responsible for applying appropriate document templates, standards, style and terminology across documents.
The incumbent works cross-functionally with internal departments and external resources on GxP related procedural documents.
The SOP/Technical Writer, supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Collaborates with GxP SMEs and teams to write, review or edit technical GxP documents (SOPs, Work Instructions, forms, checklists or manuals) in a clear, concise format
Performs document Quality review checks as required
Ensures good documentation practices are followed
Coordinates with various departments to assure GxP document written are indicative of the process and understandable to the reader
Acts as liaison between QA and the department that the document is being written for
Performs other related tasks and assignments as needed and specified by management related to document generation and control
Bachelor’s degree in a scientific discipline
Several years of technical GxP document writing experience (SOPs, Work Instructions, forms, checklists or manuals) in the pharmaceutical, biotechnology, contract research organization or related environment/industry
Ability to plan, write, review, and edit technical GxP documents (SOPs, Work Instructions, forms, checklists or manuals) and ensure that these documents adhere to applicable regulatory FDA, EMA, ICH guidelines and standards
Experience in working in a GXP environment
Strong technical comprehension and writing capability
Experience with in Process mapping and collaborative document development
Excellent attention to detail, including fact checking, logical flow, formatting, and document structure
Proficiency with Microsoft Office and use of electronic document templates
Excellent verbal and written communication skills
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Broad knowledge of ICH guidelines, FDA CFRs, EMA directives and other regulatory guidelines
Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to write high quality documents according to tight timelines
Experience working with Electronic Data Management Systems (EDMS)
Excellent interpersonal skills and attention to detail
Technical writing certification a plus
Very good German and English language skills written and spoken