Global Leader in the Biotech/Pharmaceutical Industry is expanding due to incredible spike in business- Looking for a strong Associate Director of Medical Writing for their Novato, CA Headquarters.
Would love Rare Diseases experience (but not neccesary- this is one of the MANY therapeutic areas the pharmaceutical company covers)
Company was just named #1 Biotech to watch in 2016
The Sr Manager/ Associate Director, Medical Writing will be responsible for writing and overseeing the writing of various clinical and regulatory documents and peer-reviewed scientific publications, including distribution of work to contract medical writers or agencies as needed. This is an individual contributor position with team leadership responsibilities. The Sr Manager/Associate Director Medical Writing will work closely with cross-functional teams to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The core duties of the Sr. Manager/AD medical writing are delineated below.
- Write, manage and oversee the writing of clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
- Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving)
- Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
- Distill large amounts of clinical and scientific data into essential elements for graphical display
- Partnering with lead author, oversee document review and comment resolution meetings with cross-functional teams
- Interact with external authors and key internal stakeholders to develop high-quality publications (manuscripts, abstracts, posters, slide presentations) for peer-reviewed journals and scientific congresses.
- Formulate key messages from clinical study data
- Perform literature-based research to support writing activities
- Develop best practices for authoring and reviewing
- Develop and maintain templates and outlines for key documents
- BS, MS, or doctorate in a scientific or medical field
- Five+ years in the biotechnology/pharmaceutical industry preferred
- Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission a plus.
- Demonstrated experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of publication guidelines (i.e., ICMJE, GPP) and best practices
- Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
- Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects
- Proven ability to develop and implement medical writing processes and standards
- Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues
- Flexible; adapts work style to meet organization needs
- Strong organizational abilities and experience in a multitasking environment
- Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
- Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus)
- Ability to build and maintain effective partnerships, both internally and externally
- Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels
- Rare disease experience and a strong understanding of metabolic genetics a plus