Large pharmaceutical company is looking for a Sr. Medical Writer to sit onsite in Leiderdorp. They prefer someone who has both EU and US submission experience. This person will be working on briefing documents, initial IBs, summary documents, etc. The company's European division is mostly working on urology and pain studies at this time. Typical pay for consultants in Leiderdorp is between 80-120 Euros, which is equivalent to ~$96 to $145!
This would be an ongoing contract with a start date of immediately. Below is the job description!
The individual is required to have at least a BA/BS degree or equivalent with 7+ years relevant experience (5 years with MS/MA). The individual must be able to perform independently without appreciable direction regarding technical aspects. The individual needs effective oral and written communication skills and effective interpersonal skills. The individual must be proficient with MS Word and the use of styled templates. The individual should be familiar with guidelines and regulations that apply to the assigned document type(s) (e.g., ICH E3 and FDA guidance on study tagging files/Comprehensive Table of Contents Headings and Hierarchy for study report).
Preferred: The individual has at least 5 years experience in writing regulated documents and would be considered a technical expert for the assigned regulated document
Key Tasks and Competancies: The individual must successfully interact with in-house medical writing contact and multifunctional team members (e.g., statistics, clinical, medical, regulatory, etc) and successfully complete the assigned writing responsibility.
The individual must be able to correctly use provided templates and follow provided writing guides.
Tasks may include:
Formulating a document plan in collaboration with company's scientific team (concept meeting).
Incorporating the scientific team's concepts and strategies into the provided document architecture.
Assembling and compiling information into the provided document architecture.
With direction of company or designee, building persuasive and scientific-based arguments that support the regulatory or other purpose of the document.
Adhering to principles of content re-use.
Producing a draft document that is consistent with the document plan.
Productively interacting with company scientific reviewers in review and editing of draft document.
Revise document drafts based on the review comments, addressing all comments in collaboration with responsible content authors and document scientific lead (primary conceptual leader).
Ensure data consistency and document integrity by critically evaluating comments, in collaboration with responsible content authors and primary conceptual leader as necessary, and incorporating them appropriately.
When authoring team or reviewers are in disagreement, work with primary conceptual leader to facilitate and negotiate issue resolution and decision-making and incorporate outcomes into the draft/final document.
Document the resolution and the rationale of significant decision(s).
Edit document to ensure document quality in regard to correctness of structure, content, language, and/or style.
Facilitating document approval and finalization.
The jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters. 