Expressions that Create Impressions

Syros Pharmaceuticals is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control expression of disease-driving genes. Syros has built a proprietary platform to systematically and efficiently analyze this unexploited region of DNA in human disease tissue to identify and drug novel targets linked to genomically defined patient populations. Because gene expression is fundamental to the function of all cells, the Company’s gene control platform has broad potential to achieve profound and durable benefit across a range of diseases. Syros is focused on cancer and immune-mediated diseases and is advancing a growing pipeline, including its lead drug candidates SY-1425, a selective RARα agonist for genomically defined subsets of patients identified by its platform, for a range of cancers including acute myeloid leukemia and myelodysplastic syndrome, and SY-1365, a selective CDK7 inhibitor for a range of blood cancers and solid tumors. Led by a team with deep experience in drug discovery, development and commercialization, Syros is located in Cambridge, Massachusetts.

As an integral part of the clinical team, the Associate Director of Medical Writing develops clinical and regulatory documents, ensuring the documents are of high quality and comply with internal and external standards.

Key Responsibilities

• Plan, prepare, write, edit, format, and finalize non-clinical, clinical and regulatory documents. Documents will include, but are not limited to: IND, CTA, non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, briefing books, annual reports/development safety update reports (DSURs), manuscripts and posters
• Assist in developing strategy for organizing and preparing documents for regulatory health authority submissions
• Coordinate the internal review of documents
• Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams.
• Assist in the development of templates, style guidelines, and SOPs for clinical documentation
• Ensure final document adheres to standard operating procedures (SOP), good clinical practice (GCP), and the International Council on Harmonization (ICH)
• Perform quality control review of medical writing documents
• Effectively collaborate with Research & Development colleagues, including, but not limited to, clinical research, regulatory, safety, biostatistics, clinical operations, translational medicine, and discovery

Success Factors

• Excellent oral and written communication skills for effectively interfacing with internal and external stakeholders
• Remain informed on regulations and developments in medical writing, as well as maintain knowledge of product areas, current trends, and current literature to ensure compliance
• A sense of urgency and an ability to anticipate and respond quickly to emerging information
• Entrepreneurial and passionate; enjoys working in a fast-paced, small-company environment
• Willing to work collaboratively to develop and execute on project plans
• Proactively seek out, recommend and execute process improvements
• Resourceful, creative, enthusiastic and results-oriented
• Act with integrity and respect at all times

Job Requirements

• Minimum requirement of a bachelor’s degree with 7+ years of medical writing experience in a pharmaceutical/biotechnology or CRO environment
• Experience in oncology therapeutic areas
• Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format
• Proficient in teamwork, organization, and project management
• Proficient in MS Office
• In-depth experience in US and Non-US Regulatory submissions
• Experience in working with cross-functional teams
• Excellent interpersonal and communication skills
• Flexible/adaptable in a fast-paced and dynamic work environment

Finally, the candidate will need to embrace our values:

As a team we:

• are committed to transform the lives of patients
• are pioneering in our science
• challenge each other to achieve excellence
• work with passion, integrity and respect
• like rigorous work and serious fun

We are not seeking assistance from 3^rd party agencies at this time.