Associate Director, Medical Writing

Location
Redwood City, CA
Posted
May 30, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Adverum Biotechnologies is looking for an experienced Associate Director, Medical Writer to join our team in Redwood City office.  The Medical Writing department works to advance the strategy and creation of high-quality document to support technical and operational writing support across Adverum’s program.  The Medical Writing department resides organizationally within Regulatory Affairs at Adverum. 


What you'll do:
  • Write, edit, contribute to, and manage the development of a variety of clinical regulatory documents
  • Ensure smooth and effective document management from start to finish (i.e., from template to final approved version), including but not limited to first draft authoring, coordination of review and adjudication, reference retrieval, generation of bibliographies, and participating in various document processes (e.g., QC, formatting, publishing, archiving);
  • Work closely with internal and external resources to ensure alignment among timelines for related activities, such as data communication, document authoring, document review, QC, publishing, and submission;
  • Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives, as required, ensuring adherence to applicable standards and requirements;
  • Partner with subject matter experts and other stakeholders to oversee document review and comment adjudication meetings with cross-functional teams;
  • Provide product development teams with expertise and strategic guidance on analysis and presentation of clinical and safety data, and on benefit-risk assessment in documents
  • Support the development, implementation, and improvement of best practices, the document process, and SOPs;
  • Help communicate procedure, operations, and implementation plans to the organization;
  • Distill large amounts of clinical and scientific data into summary text and analysis for clinical documents;
  • Perform literature-based research to support writing activities;
  • Develop and maintain templates and outlines for key documents;
  • Perform other duties, as assigned.

About you:
  • Bachelor’s or Advanced degree (MS, RN, PharmD or doctorate in a scientific or medical field) with at least 10 years in medical writing experience in the pharmaceutical/biotech industry
  • A minimum of 10 years’ experience of relevant experience in biotech/pharm company required, in the medical writing role, including participation in submission to the US FDA (IND, BLA) and EMA (MAA)
  • Minimum of 7 years in the biotechnology/pharmaceutical industry is preferred
  • Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
  • Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure
  • Flexible; adapts work style to meet organization needs
  • Well-organized, ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines
  • Strong organizational, communication, negotiation and interpersonal skills is required
  • Demonstrates strong organizational skills and ability to work collaboratively in a cross-functional team environment;
  • Experience participating in submissions:  INDs, BLAs, CTAs, MAAs, and other submission activities
  • Experience mentoring/training other writers
  • Ability to multi-task and work in a multi-disciplinary team, build and maintain effective partnerships
  • Able to manage time and expectations in a small group setting with limited/no administrative support
  • Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive goals
  • Dedicated to producing high-quality documents
  • Strong understanding of drug development, clinical study design, regulations (FDA and EU), ICH and other guidances, and scientific principles
  • Proficiency in Word, Excel, PowerPoint, the use of templates, email, and internet;
  • Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents
  • Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates
  • Familiarity with GCP, applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines) company SOPs and internal style guides, researches, authors, and edits
  • Work on special projects, as requested


About Us
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