Manager/Senior Manager, Medical Writing
Cogent Biosciences
Remote
Posted on Nov 27, 2024
Who We Are
Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.
Our Team
https://cogent.culturehq.com
We are seeking an experienced, collaborative, detail-oriented medical writer with a passion for medical writing. The successful candidate will lead the planning, authoring, reviewing, and QC of clinical and regulatory documents. The individual will work with cross-functional SMEs as well as independently to develop high-quality, scientifically accurate documents. In this role, the successful candidate will collaborate with and may oversee the work of contract writers. In addition, the candidate will contribute to medical writing process development.
Responsibilities
- Employ scientific knowledge and analytical skills to author high-quality, scientifically accurate clinical and regulatory documents which may include clinical study protocols and amendments, clinical study reports, Investigator’s brochures, common technical document modules, and briefing books
- Facilitate document reviews and lead round-table meetings to achieve consensus among stakeholders on document content and strategy
- Ensure consistent messaging across documents as appropriate
- Represent the Medical Writing department on clinical study teams
- Perform and/or manage quality control reviews of clinical and regulatory documents as needed
- Collaborate with and manage contract writers as needed
- Contribute to the development and implementation of medical writing processes
- Adhere to regulatory standards and company SOPs
- Perform other medical writing related duties as assigned
Requirements
- Bachelor’s degree
- Manager: 5+ years of medical writing experience; Sr. Manager: 7+ years of medical writing experience, or with fewer years of experience for individuals with an advanced degree [MS, PhD, MD, PharmD]
- Strong knowledge of FDA and ICH guidelines, GCP, and applicable regulatory processes related to document preparation
- Proficient in researching and understanding scientific literature and distilling complex topics clearly and accurately
- Proficient in interpreting and critically analyzing data and summarizing it clearly and accurately
- Strong project management and time management skills
- Excellent interpersonal, written, and verbal communication skills
- Self-motivated and effective in working with cross-functional teams
- Strong computer and software skills (eg, Word, Excel, PowerPoint, Adobe suite, Veeva RIM, SharePoint) and ability to learn new computer applications
- Experience as a key contributor or lead author for submissions of regulatory documents is preferred
Our Locations
Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.
Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.
Our Offer To You
To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.