Alnylam was founded in 2002 on a revolutionary vision and bold mission which remain firmly in place today. We are leading the translation of RNAi as a new class of medicines with a core focus on RNAi therapeutics toward genetically defined targets for the treatment of serious, life-threatening diseases with limited treatment options for patients and their caregivers. In January 2015, we announced our “Alnylam 2020” guidance that reflects our expected transition from a late-stage clinical development company to a multi-product commercial-stage company with a sustainable development pipeline. Alnylam is proud to have been recognized as one of The Boston Globe’s Top Places to Work in 2015 and 2016.
Senior Medical Writing Operations Associate
The Senior Medical Writing Operations Associate will be responsible for providing support to Medical Writing in various capacities to ensure the highest quality documents are produced. This will include document quality review (including content, formatting, and document consistency), publishing, and archiving of medical writing documents according to quality standards and defined timelines.
Summary of Key Responsibilities:
- Perform basic electronic publishing quality checks of hyperlinks and bookmarks for medical writing documents to ensure they meet Alnylam submission-ready guidelines
- Ensure MS Word submission components are formatted in accordance with Alnylam style and regulatory requirements and provide troubleshooting of formatting
- Serve as subject matter expert for format QC review and submission-ready preparation of medical writing documents (protocols, IBs, CSRs)
- Ensure medical writing documents are stored or archived appropriately
- Work in partnership across expertise areas to collect, compile, assemble, and publish clinical study reports (CSR) appendices
- Create, update, and maintain medical writing templates that meet global regulatory requirements and provide assistance with templates and style guide
- Collaborate effectively with Clinical Development and Regulatory Operations
- Perform administrative functions as directed by Medical Writing management to support projects and to ensure the smooth operation of the expertise area
- Assist with writing, reviewing, finalizing, and maintaining internal best practices and SOPs pertaining to PDF preparation, QC, and document management.
- Provide content quality control (QC) review of medical writing documents (eg, CSRs, clinical sections of investigator’s brochures, NDA/MAA clinical sections, clinical protocols)
- May participate in the development, implementation, and maintenance of medical writing systems and software (eg, electronic document management systems, reference databases, document review software)
- May assist the Medical Writing team in the generation of CSR shells and/or the preparation of in-text tables and figures with oversight from the medical writer.
- Bachelor's degree in a relevant technical or scientific field, or an equivalent combination of education and experience
- 2+ years of biotechnology/pharmaceutical or CRO experience with document QC and electronic publishing in a regulatory environment
- Confidence and ability to learn new software tools is essential
- Must be flexible, detail-oriented, and possess good analytical and problem-solving skills
- Successful track record of managing multiple projects in a fast-paced and deadline-driven environment
· Ability to interpret and follow health authority/ICH PDF requirements and internal processes
· Familiarity with eCTD requirements for applicable documentation
- Must be proficient with Microsoft Windows, MS Word, Excel, PowerPoint, and Adobe Acrobat; exposure to StartingPoint templates, SharePoint and CSC Toolbox is a plus
- Experience with electronic document management systems is a plus
Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.