Monte Rosa Therapeutics is seeking a  Senior Medical Writer to work directly with Clinical Operations, Clinical Research and Drug Safety groups on  various clinical and nonclinical regulatory documents ( e.g. study protocols, Investigator Brochures, Clinical Study Reports, Annual Reports, INDs, and NDAs) as well as clinical and nonclinical publications (e.g. abstracts, posters, and manuscripts). This position will assume lead writing responsibility on up to 5 clinical studies potentially leading to an NDA, including both regulatory and publication documentation. This position will also lead writing assignments on other programs in early development.  

Writes clinical protocols, clinical study reports, investigator’s brochures, annual reports, INDs, IMPDs, and NDAs and other regulatory documents in conjunction with the project team with minimal supervision

Writes, reviews, and/or edits publications (manuscripts, abstracts, poster presentations, etc.)

Drives document writing and review processes

Develops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members

Coordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization

May manage outsourced writing projects with minimal supervision

Assists in the development and maintenance of SOPs and writing tools, such as templates and style manuals

Provides training on medical writing templates, SOPs, and processes within the department and across departments

Contributes to the development of electronic document systems and tools

Provides quality control (QC) review of various regulatory and medical communications documents

Provides project team(s) with guidance and problem resolution related to document generation

Takes the initiative to solve problems, exercising sound judgment and appropriate flexibility within a dynamic environment

Acts as an authoritative resource within specialty area to internal and external resources

Works effectively with colleagues from other departments in team situations

This position requires a bachelors degree in a life sciences discipline and a minimum of 12+  years biopharmaceutical industry experience, or a masters/PhD degree in a life sciences discipline and a minimum of 2-5 years biopharmaceutical industry experience.

Experience preparing clinical regulatory documents and scientific publications is crucial.

Prior NDA/BLA/MAA submission experience, including eCTD, is preferred.

Must have a solid understanding of FDA/ICH guidelines and GCPs.

Must have strong written and verbal communication skills, and expert abilities in Microsoft Word, Excel, and PowerPoint; experience with Adobe Acrobat preferred.

Must have the ability to coordinate and prioritize multiple projects in a fast-paced environment with little supervision.