Director, Medical Writing

Zenas BioPharma; Waltham (MA); On-site; USD 178,000 - 223,000; Full time

Job summary

Join a forward-thinking biopharmaceutical company as a Director of Medical Writing, where your expertise will help shape the future of immune-based therapies. In this pivotal role, you will lead the development of high-quality regulatory documents and collaborate with cross-functional teams to ensure compliance with industry standards. This dynamic environment offers the chance to work on groundbreaking projects that aim to improve the lives of patients with autoimmune diseases. If you're passionate about making a difference and thrive in a fast-paced setting, this opportunity is perfect for you. Embrace innovation and drive your career forward with us!

Benefits

Annual Performance Bonus

Equity Options

Comprehensive Benefits Package

Qualifications

• 7+ years of medical writing experience in pharma or CRO.
• Extensive knowledge of AMA style guide and regulatory requirements.

Responsibilities

• Lead writing strategy and manage timelines for documents.
• Collaborate to establish SOPs and quality control checklists.

Skills

Medical Writing

Regulatory Document Development

Clinical Research

Project Management

Biostatistics

English Grammar

Collaboration

Education

Bachelor’s Degree in Scientific Discipline

Tools

Microsoft Office

Veeva Vault

Medical Writing AI Tools

Job description

1 week ago Be among the first 25 applicants

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas of high unmet medical need while meeting the value requirements of the dynamic global healthcare environment. The company’s pipeline continues to grow through our successful business development strategy. Our experienced leadership team and network of business partners drive operational excellence to deliver potentially transformative therapies to improve the lives of those living with autoimmune and rare diseases.

We are seeking top talent who share our commitment to patients and have a track record of success in acquiring, developing and commercializing products across the globe. Our colleagues have an opportunity to engage in a fast-paced learning environment and experience individual and organizational success as we work towards becoming a global immunology and autoimmune disease leader, while living our values of Transparency, Relationships, Urgency, Excellence and Innovation – TRUE Innovation!

Position Summary

The Director, Medical Writing (MW) will be responsible for assigned programs and projects which may include the development, and the delivery of clinical and scientific data to regulatory agencies, healthcare professionals, and other stakeholders. This role also involves contribution to the development and maintenance of standard operating procedures (SOPs), style guides, and quality control checklists that drive consistency across documents and processes. We seek a highly qualified individual for this role that includes a proven track record in Medical Writing working directly with project teams and external vendors to deliver high-quality submission-ready documents (eg, INDs, filings, protocols, IBs, CSRs, etc.) and publications (abstracts, presentations, journal articles). This position will report to the Executive Director, Medical Writing.

Key Responsibilities

• Lead writing strategy, drive document content and organization, develop and manage timelines, and identify relevant stakeholders for assigned programs/projects
• Collaborate with MW organization to establish functional SOPs, style guides, and quality control checklists that drive consistency across documents and processes
• Advise on document development, ensuring adherence to regulations, ICH guidelines, and SOPs.
• Independently author and provide guidance to team members in the creation of clear and concise, submission-ready clinical and regulatory documents
• Act as subject matter expert for development of data transparency deliverables
• Plan strategically, anticipate problems, and recommend process improvements to address current and future needs
• Perform other medical writing related duties as assigned
• Contributes to a supportive team culture that promotes open-minded thinking and collaboration by leading through example
• Ability to change direction quickly or pivot strategy when needed
  
  

Qualifications

• Bachelor’s degree in a scientific discipline or systems technology or equivalent combination of education and experience.
• 7 + years of medical writing capacity in pharma/biopharma/contract research organization (CRO).
• Extensive knowledge of English grammar and American Medical Association (AMA) style guide.
• Demonstrated experience directly leading clinical and regulatory document development, managing project work, and working collaboratively with both internal and external writers/vendors.
• Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs.
• Working knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory, and medical terminology.
• Computer proficiency in Microsoft Office (including Word, Excel, PowerPoint, and Project Management tools) with some experience with Veeva Vault products and MW artificial intelligence (AI) software/writing tools would be a g plus.
• Ability to work effectively in a fast-paced, collaborative, start-up culture with evolving processes.
• Demonstrates flexibility to work non-traditional work hours when needed, given international operations across time zones.
  
  

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $178,400 to $223,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.

Zenas BioPharma is proud to be an equal opportunity employer. We are committed to fostering an environment where diversity is valued. All qualified applicants will receive consideration for employment based on merit, qualifications and the needs of the business.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Health Care Provider

Referrals increase your chances of interviewing at Zenas BioPharma by 2x

Get notified about new Medical Director jobs in Waltham, MA.

Vice President International Patient Center

Head (Executive Director) Rare Disease, US Medical Affairs

Massachusetts, United States $150 - $210 2 weeks ago

Boston, MA $160,000 - $180,000 2 weeks ago

Director, Scientific and Medical Education

Director of Consulting Services - Medical Device Testing

Senior Vice President, Clinical Development & Medical Affairs

Boston, MA $300,000 - $350,000 3 weeks ago

Medical Director, Drug Safety & Pharmacovigilance

VP, Associate Chief Nursing Officer - Medical, Surgical, Procedural

Senior Medical Director, Drug Safety & Pharmacovigilance

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.