Director Medical Writing

Location
Redwood City, CA
Posted
May 18, 2021
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
Adverum Biotechnologies is looking for an experienced 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. 

The Director, Medical Writing, will be responsible for working cross-functionally with internal customers and stakeholders to develop, implement and maintain a standardized document development process for clinical and regulatory documents.  This includes, but is not limited to directing, authoring, editing and providing input to clinical documents, documents required for regulatory submissions to the health authorities, presentations, posters, publications and regulatory fulfillment.  He/she may also author/edit and/or direct the development of pre-clinical documents.  The Medical Writer will be responsible for managing external resources in support of the Medical Writing requirements.  Preference would be for someone to be on-site with flexibility to work remotely.  A strong understanding of drug development, clinical study design, regulations and scientific principles is required.  This position requires adherence to multiple simultaneous timelines, working to project deadlines.  The successful candidate must have the ability to handle multiple projects efficiently within a collaborative team environment.  The successful candidate will possess excellent leadership skills.  He/she may also provide line management, mentoring and people development, and performance management as well as lead the development and implementation of department policies and procedures.  Experience in a pharmaceutical, biotechnology, or clinical research organization setting is required for this role.  This position will report directly to the VP, Regulatory Affairs and will work closely with the Clinical and other cross-functional teams.
What you'll do:
  • Lead the provision of services provided by the Medical and Scientific Writing group; accountable for the group’s performance within the organization and the development of individual contributors within the group
  • Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data
  • Participate in cross-functional team strategy discussions, which may include nonclinical, clinical, and regulatory strategies
  • Engage in product development team(s) forecasting and planning for all program-specific document deliverables. This includes partnering with key company stakeholders to help integrate nonclinical and clinical trial data into concise and compelling reports such as scientific abstracts, posters, manuscripts, Advisory Committee presentations, exhibits, etc., as needed; 
  • 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; 
  • Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data
  • Use scientific expertise to write, review, and edit science-based reports such as the clinical protocol, Investigator’s Brochure, clinical study report, informed consent, risk/benefit analysis and integrated summary, IND sections, Briefing Documents, annual reports, and verbal presentations and abstracts
  • Partner with the regulatory team to prepare other documents, as needed, for submission to Health Authorities 
  • Ensure continuous awareness of the medical writing activities, plans, scope(s) of work and ways of working across the organization
  • Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports
  • Work with clinical and regulatory teams to be sure that all deliverables are in accordance with regulations, standards, and guidelines
  • Must meet ICH, GLPs, and GCPs guidelines, a writing style guide, and template, as appropriate
  • Provide oversight of document quality and consistency; documents as well as consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier or briefing package
  • Lead document review and comment resolution meetings with cross-functional teams; 
  • Build and maintain a positive working relationship with key stakeholders, team members and vendors
  • Direct, train, and assist other medical writers in the writing and editing of clinical and regulatory documents
  • Other responsibilities may be assigned as needed


About you:
  • 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)
  • Fit with Adverum culture
  • Experience in a leadership role within a Medical Writing function; experience having responsibility for the performance and development of staff
  • 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
  • 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 effectively 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
  • Assists in the day-to-day operational activities and other assignments as needed and specified by management 
  • 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 
  • Travel – 10% (if needed) 
  • 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