BlueRock Therapeutics Director, Medical Writing in Cambridge, Massachusetts
Who is BlueRock?
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.
The convergence of cell biology and genetic engineering is creating fundamental new ways to impact disease. Founded in 2016 to capitalize on these technological breakthroughs, we are advancing our novel cell+gene platform to develop, manufacture, and deliver an entirely new generation of authentic and engineered cell therapies across three therapeutic areas: neurology, cardiology, and immunology.
What Are We Doing?
Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.
We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.
We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.
Description of Position:
The incumbent will be responsible for supporting preparation of regulatory submission documents to support global clinical development, product registration, and post-approval life cycle management. This position will provide regulatory support on projects by working with senior regulatory management to implement regulatory strategy and development plans and oversee regulatory submissions. Individual will also maintain awareness of global regulatory environment for cell therapies including accelerated review programs and the impact on product development programs.
Manage assigned medical writing activities associated with individual studies and study documents, including cross departmental communication, and timelines
Manage outsourcing Medical Writing vendor overseeing coordination activities, and timeline management
Author or support the writing and reviewing of a variety of documents, including but not limited to:
Clinical study protocols and clinical protocol amendments
Clinical study reports
IND submissions and annual reports
Integrated summary reports
Clinical journal manuscripts, clinical journal abstracts, and client presentations.
Manages the cross functional review process to ensure timely completion consistent with established submission timelines.
Leads comment resolution team meetings for assigned documents
Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
Interacts with department head and staff members in Clinical Operations, Clinical Development, Regulatory Affairs, and other departments, as needed, to produce writing high quality deliverables.
Coordinates Regulatory submissions across multiple Health Authorities
Serves as peer reviewer on internal review team providing review comments on draft and final documents.
Adheres to established regulatory standards as well as Standard Operating Procedures, and approved templates when completing medical writing projects.
Performs on-line clinical literature searches, as applicable.
Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
Authors assigned departmental procedures.
Manages Departmental document archiving process
Develop assigned departmental procedure, as needed
Minimal travel may be required (less than 25%).
Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
10 years’ experience in Medical Writing for Regulatory Submissions
Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.
Strong proficiency in Word, Excel, PowerPoint, email, and Internet. Experience with Veeva Vault, Starting Point, and Sharepoint preferred
Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.
Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs.