Director/Sr, Medical Writer
The Director/Senior Director in Medical Writing will provide leadership, direction, and competence for the development of high-quality clinical research documentation, that adheres to departmental standards and regulatory guidelines, in support of drug development, product registrations, and product marketing to meet the company’s global strategic, scientific, regulatory, and commercial goals. The Director/Senior Director understands the principles of scientific writing, writing with the audience in mind, and conveying messages in a clear and concise manner. The Director/Senior Director will apply advanced knowledge of relevant regulatory requirements and company policies to assess document requirements and identify information gaps or other potential issues. The Director/Senior Director offers clear leadership and extensive accountability, strategic vision, and planning direction at the global function level for clinical/regulatory documents.
In this role, one will need to be hands-on, directly with teams and management to oversee and produce high-quality clinical program documents to support regulatory submissions and scientific communications while simultaneously building up the team. There will be an opportunity to expand the medical writing function into a central resource to support both research and CMC teams in pertinent non-clinical and CMC sections of the regulatory submissions.
What you'll do:
- Project manages the timely production and completion of reviews of high-quality documents to support submissions to regulatory authorities
- Works with key company stakeholders and cross-functional teams to help integrate nonclinical and clinical data into concise and compelling reports
- Reviews, analyzes, and summarizes data to be used in clinical study reports or other high quality scientific communications and regulatory documents
- Develops, implements, and uses templates based on international guidelines and regulations; develops a writing style guide and template, as needed
- Considered an internal expert in all aspects of regulatory medical writing; demonstrates competence in writing, editing, and reviewing clinical study reports, Investigator’s Brochures, registration dossier modules, and other clinical regulatory documents per company and other guidelines. Knowledge of regulatory guidance and industry standards
- Review pertinent literature, evaluates applicability, and incorporate that information into clinical documents, as appropriate
- Issue resolution skills, being able to lead document review and comment resolution meeting(s);
- Participate in cross-functional team strategy discussions, which may include nonclinical, clinical, CMC, and regulatory strategies
- Solves problems associated with medical writing scope of work, seeks advice from management and others as needed, and exercises negotiation and communication skills with project team members;
- Execute literature reviews and competitive landscape research contributing to development strategy
- Interact with internal stakeholders and external service providers to ensure the timely development, review, and publication of documents
- Consult cross-functionally to develop communication goals and objectives, and plan to best communicate scientific messages
- Create tables, charts, figures, and other visual display elements for presenting clinical data
- Other duties or special projects, as assigned.
- BS, MS, RN, PharmD or PhD in Life Sciences (or related field) with a minimum of 10 years of relevant experience
- Leadership presence in complex clinical regulatory writing projects, including at least one marketing application (e.g., NDA/BLA, MAA)
- Good understanding of experimental methods, research design, and statistical analysis
- Ability to analyze medical data and interpret its significance within a biopharmaceutical setting
- Excellent understanding of the drug development process
- Experience authoring clinical regulatory documents
- Motivated, detail-oriented, self-directed, and able to work autonomously with limited guidance
- Exceptional oral and written communication skills
- Demonstrate leadership ability (influencing skills, strong writing skills, mentoring other writers)
- Attention to detail and accuracy Previous management experience in the medical writing function;
- Proficient in Microsoft Office
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation