Based in South San Francisco, California, Onyx Pharmaceuticals is an Amgen subsidiary, engaged in the development and commercialization of innovative therapies for improving the lives of people with cancer. At Onyx, our success begins with our employees. The progress we have made as a company reflects the talents of the individuals who have come together to develop possible new therapeutics for treating cancer.
Onyx is seeking talented and dedicated individuals of the highest caliber who are passionate about the pharmaceutical industry and driven to change the way cancer is treated. We are proud to be an equal opportunity employer who respects individual differences and recognizes each employee as an integral member of our company. Our culture is one where everyone can learn and develop personally and professionally.
Onyx is seeking a Senior Principal Medical Writer of the highest caliber who is passionate about the pharmaceutical industry and driven to change the way cancer is treated.
Responsibilities of this role include:
* Writing, editing, reviewing, and formatting documents that conform to domestic and/or international regulatory submissions and internal document standards, while meeting project timelines.
* Carries out core-level responsibilities with minimal supervision.
* Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly.
* Provide medical writing support for the preparation of manuscripts, abstracts, posters, and review articles.
* Participates in document QC process.
* As lead writer, plan and manage the documentation process, project timelines (in collaboration with Project Management), and resource requirements on large medical writing projects.
* Train and supervise other medical writers.
Essential Duties include:
* Works with contributing authors to plan, write, and edit regulatory documents
* Formats text, tables, and graphs in regulatory documents to meet standards for electronic regulatory submissions
* Attends meetings about document(s) in development (e.g., clinical study report [CSR] team meetings), and provides attendees with document status reports
* Incorporates comments into documents produced by key stakeholders, including Medical Writing and Quality Assurance audit reviews
* Keeps supervisor, team, and reviewers informed of date when documents will be ready for review; provides project managers with document status reports as needed
* Uses an electronic document management system (eDMS [e.g., Livelink]) to upload documents and share them with team members
* Performs QC review of documents, under the oversight of the Senior Director, Medical Writing, as assigned
* Reviews and edits documents for organization, clarity, consistency, use of English language/grammar, conformance with regulatory requirements, and scientific standards; resolves errors and inconsistencies in clinical data with project team members
* Provide editorial and peer-review support for other document types (e.g., manuscripts or presentations) as needed
* Works effectively with other cross-functional groups on the document development team
* Provide writing support to departments other than Clinical Development, as needed or requested
* Develop processes to support medical writing projects and write SOPs to support those processes
* Help train other medical writers
* Stays current on medical writing best practices and regulatory guidelines; expands knowledge/understanding of medical and scientific issues related to document development through professional associations, publications, and/or meetings
* Advanced degree in life sciences
* 5+ years of medical writing/editing experience in the biotechnology, pharmaceutical or medical device industry
* 8+ years product development experience in the biotechnology, pharmaceutical, or medical device industry; more extensive industry experience may compensate for less medical writing experience
* Ability to manage and/or train junior writers and/or contract medical writers
* The ability for a clear, high-quality scientific writing style in the English language, and the abiltiy to independently analyze and synthesize data from a broad range of disciplines.
* Experience writing, editing, reviewing, and formatting clinical regulatory documents (eg, clinical study protocols, clinical study reports, investigator brochures, and sections of INDs, NDAs and/or BLAs)
* Advanced scientific/technical reading, writing, and editing skills
* Expert knowledge of Microsoft Office 2007 and/or 2010, particularly Microsoft Word
* Intermediate to advanced knowledge of Adobe Acrobat (full version, not the Reader)
* Intermediate to advanced knowledge of Microsoft PowerPoint
* Working knowledge of graphics software applications
* Experience preparing electronic documents for publication
* Comfortable using document templates, styles, and complex table formatting methods in Microsoft Word
* Experience with an electronic document management system (eDMS), such as Livelink, preferred
* Thorough knowledge of ICH Guidelines associated with regulatory submissions (BLAs and/or NDAs, INDs) and other regulatory documents (CSRs, IBs, and clinical study protocols)
* Intermediate to advanced knowledge of biostatistical and clinical research concepts
* Intermediate to advanced understanding of the drug, biologic, and/or medical device product development process
* Expert knowledge of and ability to apply style rules from the American Association Manual of Style, 10th Edition
* Exceptional communication, interpersonal, organizational, and problem-solving skills
* Ability to work with focus and great attention to detail
* Ability to successfully work with a wide range of personalities
* Exceptional ability to manage multiple projects in a fast-paced environment, with changing priorities and significant time pressures
* Ability to work independently with limited supervision; must be a self-starter
* Has demonstrated highly effective problem-solving, planning, and organizational skills.
* Ability to instruct others
* Demonstrated ability to competently lead cross-functional document development teams
Amgen is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.