Seattle Genetics Inc.
Bothell, WA, United States
Healthcare, Pharmaceutical, Sciences, Writing
Summary: The Pharmacovigilance Medical Writer will be responsible for authoring and revising key drug safety- focused documents and reports for submission to the FDA and other regulatory health agencies. They will work closely with medical and safety colleagues to prepare accurate and concise analyses of safety data to support development of new treatments as well as support post-marketing safety activities for approved agents. Responsibilities: Lead the authoring and editing of periodic aggregate safety reports, including but not limited to PBRER/PSUR, PADER, DSUR, and IND annual reports in collaboration with Safety Evaluation and Risk Management (SERM), safety scientists, and medical colleaguesAuthor, write, and edit RMPs and REMS in collaboration with Safety Evaluation and Risk Management (SERM), safety scientists, and medical colleaguesIn collaboration with study medical writers review safety sections for clinical protocols, IBs, subject consent forms, and other clinical/regulatory documentsUnderstand relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and other annual reports and/or deliverablesAssess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issuesProvide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submissionProvide project teams with expertise and strategic guidance on analysis and presentation of safety data and on benefit-risk assessment in documentsAuthor safety summaries to support communication of relevant safety information both internally and externallyProduce high quality, accurate, and fit- for-purpose evaluation documents with clear conclusions, in response to internal or regulatory authority request for safety reasonsReview the worldwide medical/scientific literature to identify signals and applicable information for inclusion in aggregate safety reports in collaboration with SERM colleaguesDraft regulatory response documents such as PRAC assessment reportsDraft other medical writing deliverables as needed Requirements: Minimum of 3-5 years scientific experience in the biopharmaceutical industry; post-doctoral research may be considered in lieu of industry experienceExcellent written and verbal communication skills with the ability to interpret and present statistical and clinical data to varied audiencesKnowledge of FDA and EMA regulations, ICH guidelines, Good Clinical Practices and the drug development processKnowledge of drug safety/pharmacovigilance practices and toolsMust have the ability to coordinate and prioritize multiple projects in a fast-paced environment with limited to little supervisionBackground in oncology drug development is a plusEducation:Minimum of a Bachelor’s degree in life sciences field with pharmaceutical industry experience in safety, regulatory, or clinical areas is required. Transferrable skills in other clinical settings may be considered. Masters or doctorate degree qualification in life sciences or public health preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.
Seattle Genetics Inc.
Website : http://www.seattlegenetics.com
Seattle Genetics is a biotechnology company focused on developing and commercializing innovative, empowered antibody-based therapies for the treatment of cancer. We are the industry leader in antibody-drug conjugates (ADCs), a technology designed to harness the targeting ability of monoclonal antibodies to deliver cell-killing agents directly to cancer cells. ADCs are intended to spare non-targeted cells and thus reduce many of the toxic effects of traditional chemotherapy, while potentially enhancing antitumor activity.