About Morphic Therapeutic
Morphic Therapeutic is a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, including autoimmune, cardiovascular and metabolic diseases, fibrosis and cancer. In collaboration with Schrödinger, Morphic is advancing its pipeline and discovery activities using its proprietary MInT technology platform which leverages the Company’s unique understanding of integrin structure and biology. For more information, visit www.morphictx.com.
Morphic is advancing both partnered and fully-owned oral integrin therapeutic candidates with the initial clinical trials beginning in 2020. Our immediate focus is on the areas where the clinical activity of antibody inhibitors of integrins is precedented, thus enabling a rapid path to clinical proof-of-concept. Morphic Therapeutic is located in the AstraZeneca BioHub in Waltham, MA. We are seeking a highly talented and motivated individual to join our culture of teamwork, craftsmanship, tenacity, compassion, integrity, and beauty.
As a principal medical writer, you will be responsible for developing clinical and regulatory documents required to support clinical trials, regulatory submissions, and external publications of Morphic’s clinical programs. You will be empowered to develop the writing strategy and implement the writing process to ensure successful preparation and timely completion of high-quality submission-ready documents.
Reporting to the Director of Medical writing, the principal medical writer serves as the medical writing lead and subject matter expert for assigned medical writing projects in supporting clinical development pipelines. The principal medical writer will participate in cross-functional teams, influence decision making, and lead strategy discussions related to document development, as well as make recommendation in process improvements within the department and participates in discussions to implement change.
Essential Job Functions:
• Serves as the medical writing lead for developing clinical documents, including protocols, clinical study reports, investigator brochures, clinical sections of t CTD, and other regulatory submissions documents
• Drives the planning and writing strategy and manages the process of developing clinical documents required for regulatory submissions or in support of the clinical development pipelines
• Collaborates with cross-functional teams and manages timeline and communications and expectations to create documents with the highest quality and scientific accuracy
• Leads the development of medical communication materials for publications (i.e., abstracts, manuscripts, posters etc.)
• Oversees projects assigned to vendors/contractors, coordinates the activities between Morphic and vendors/contractors, reviews and critics of the contributions, and ensures resolution of issues
• Represents medical writing on cross-functional teams and serves as medical writing SME for related projects, process, and standards
• Responsible for quality and compliance with internal and external standards and guidelines related to document preparation
• Participates in or leads initiatives to improve medical writing processes and standards.
• Bachelor’s or Master’s degree or equivalent in a scientific or health care discipline
• Minimum of 6 years of experiences as lead writer in preparing any type of clinical regulatory document (e.g., protocols, CSR, IB, clinical sections of CTD etc.) in the pharmaceutical and/or biotech industry
• Demonstrated understanding of clinical research, drug development process, and applicable ICH guidelines and regulations required by the FDA and international health authorities in document content requirement, preparation, submission, and lifecycle management
• Strong data analytical skills and ability to present clinical data objectively in a clear, concise format in keeping with industry standards
• Expert proficiency with templates, style guides, advanced word processing and presentation skills in MS office and PowerPoint, and collaborative authoring and document review system (e.g. SharePoint, PleaseReview etc.)
• Strong project management and organization skills for managing multiple projects
• Excellent oral and written communication skills and attention to details related document accuracy, consistency, and grammar
• Demonstrated problem solving and interpersonal skills; works as a true team player and be effective in facilitating communication with cross-functional teams and drives result
• Advanced degree (PhD or PharmD) in a life science or health care discipline
• Experience as lead writer for regulatory submissions (IND, NDA, or BLA)
• Managing medical writing activities for a major US or global regulatory submission
• Experience in publication planning and/or publication development
• Experience with the gastroenterology, oncology, hepatology (e.g. IBD and/or PSC), and pulmonary therapeutic areas
Morphic Therapeutic is an equal opportunity employer committed to providing an environment that maximizes our employees’ development and achievement goals. We strive to treat each employee as an individual, as we seek to foster a spirit of teamwork to help change patients’ lives. In addition to a competitive compensation and benefits package that includes medical, dental and vision coverage, a 401K and a generous vacation and holiday schedule.