Please contact your Administrator to change your authorization settings.
Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF- signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.
Job Summary:
Independently author, review, and manage clinical documents as the lead medical writer. Lead strategy discussions for document development and contribute to medical writing process development. Manage contract medical writers.
Primary Responsibilities:
- Independently authors high-quality, scientifically accurate, complex clinical documents, ensuring consistency between related documents
- Leads document-related meetings, participates in cross-functional team meetings
- Manages medical writing timelines and communicates with team to maintain awareness of expectations, milestones, and deliverables
- Manages program deliverables across a growing portfolio
- Evaluates medical writing resource needs to meet program and study deliverables
- Oversees outsourced medical writing deliverables
- Performs and/or manages quality control reviews of clinical and regulatory documents
- Contributes to the development and implementation of medical writing processes
- Ensures alignment with International Conference on Harmonization (ICH) guidelines, regulatory requirements, and Keros's policies and processes
Attributes:
- Highly efficient and collaborative, with strong attention to detail
- Ability to create strong, collaborative working relationships
- Excellent written, interpersonal, and communication skills
- The ability to work effectively in a fast-paced environment
- Effective in identifying issues and driving team towards creative solutions and smart decisions
- Ability to work effectively, with minimal structure, as well as determine when structure is needed and develop related procedures
- Ability to learn and understand new therapeutic areas quickly and comprehensively
Qualifications:
- B.S./B.A. required; M.A. or Ph.D. preferred
- At least 5 years of experience writing clinical and documents for a pharmaceutical or biotechnology company
- Experience across Phase 1 to Phase 3 clinical development, rare disease experience is advantageous
- Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
Our Diversity, Equity & Inclusion Mission Statement: Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.
Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.