The Medical Writer works independently and is responsible for all medical writing activities across our client including clinical documents, regulatory documents, presentations and publications. He/She will be responsible for the efficient preparation of high quality, strategically aligned, consistently framed and properly positioned medical writing deliverables that support the requirements of a drug development program.
* Manages the regulatory document portfolio required for a project (e.g., IND, BLA), provides direction on document content; provides innovative solutions to cross-functional areas.
* Prepares, edits, finalizes protocols, protocol amendments, preclinical study protocols, investigator brochures (IB), synopses, regulatory documents, briefing documents, safety updates, related clinical documents, and reports under strict timelines.
* Supports the writing activities of abstracts, posters, presentations, and manuscripts.
* Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
* Develops/revises and maintains SOPs for company document production, editorial style guides, document templates, document publishing and content management systems implementation. Ensures key messages are clear and consistent within and across documents.
* Collaborates cross-functionally with our client's team members (e.g., regulatory, clinical, quality, biometrics, CMC, R&D) to ensure accurate and timely completion/delivery of high quality, scientifically justified documents.
* Ability to work independently and collaboratively, as required, in a fast-paced team environment consisting of internal and external team members. Procures and manages external medical writing resources (e.g., Contract Research Organizations (CRO), independent medical writers, etc.
* Prepares internal guidelines for document preparation and templates for regulatory and clinical documents that are consistent with FDA, EMA, ICH, and submission guidelines.
* Prepares and implements writing guidelines in compliance with standards issued by the AMA, AMWA and other internationally recognized writing bodies.
* Develops the strategy for document preparation and the document review processes, including the management of timelines that meet or exceed company standards.
* Facilitates document review meetings and discussions.
Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
* Finalize study reports, which are suitable for electronic submissions in regulatory filings, by conducting appropriate formatting and hyperlinking per specified writing guidelines.
* Supports the production of documents and presentations for symposia and advisory committees.
* Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
* Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity.
* Support audits as required.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.