Medical Writing Strategist Oncology
Employment Type: Full-Time
Medical Writing Strategist Oncology | Career USA Skip to main navigation Search Contact us Bayer u.s. Bayer Group Career USA Home Why Bayer Why Bayer We pride ourselves in being research-driven, with businesses in CropScience and HealthCare. We are also proud of our environmental record, our safety performance, and our manufacturing expertise. You can only imagine our pride at being named one of Fortune magazine's most admired companies. 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Overview Search Home Why Bayer Overview Innovation & Solutions Development & Teamwork Reputation & Impact Benefits & Rewards Overview Competitive Pay Work Life Programs Wellness Programs Benefits Values & Stories Overview David against Goliath Singapore's Supertrees Sky-high vegetables Bringing light into darkness Rice for a hungry planet Bridging Distances Healthy for Life Working at Bayer Overview Students & Graduates Overview Information Technology Programs for Interns and College Graduates Bayer CropScience: Sales Excellence Internship Program International Program for Financial Management (U.S.) Commercial Excellence Leadership Program: Sales Excellence Associate Innovation Center at University of Illinois Experienced Professionals Temporary & Project Roles Military Professionals & Protected Veterans Meet our Employees #Bayer360 Virtual Reality Career Experience Diversity & Inclusion How to Join Us Overview How To Apply Managing Your Profile Your Interview Onboarding FAQ Network With Us Search Search Search Breadcrumb Home Medical Writing Strategist Oncology Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change. Apply Online Medical Writing Strategist Oncology YOUR TASKS AND RESPONSIBILITIES He/She serves as an advisor for the entire oncology area on complex scientific and regulatory topics related to study and project level clinical document development in all indications for the assigned clinical program; He/She acts as the oncology medical writing compound expert and assumes responsibility for planning, development (with input from appropriate expert functions) and implementation of the messaging strategy and content of all clinical documents for the assigned compound; He/She drives the overall design of clinical submission documents, validates individual study protocol design, key messages of the clinical study report and other clinical submission documents, for the assigned clinical program; He/She works with the CDLs, Project/Expert Statisticians, and other relevant functional stakeholders to develop the project level data presentation strategy and messaging standards for the assigned clinical program; He/she keeps abreast of all relevant scientific topics, regulatory agency medical review and submission guidelines and drug approval requirements for oncology products. Provides expert input on the interpretation and implementation of regulatory guidelines for the development of company-internal processes, templates and scientific content needed for the development of all clinical document types; He/She represents the function with respect to medical writing aspects of oncology clinical development programs and products to internal and external stakeholders. These include regulatory agencies, industry and healthcare associations, collaborations/business partners, etc; He/She provides consultation and mentors associate submission and submission medical writers; The incumbent is responsible for leading the planning, design and development of regulatory submission document and content strategy for assigned clinical development programs, and for leading cross-functional writing teams supporting high priority drug projects; These projects will be on the critical path to drug submission and approval. Typically, peak sales for a product registered globally is in the 200-500 million euro range but may exceed 1 billion euros. Therefore, the success of the Medical Writing Strategist position has a significant impact on overall Division profitability. WHO YOU ARE Qualification & Competencies: This position requires a Master’s degree in natural sciences and minimum of 10 years’ experience in the pharmaceutical industry, or a PhD in natural sciences and a minimum of 8 years’ experience in the pharmaceutical industry; In all cases, the candidate should have at least 8 years’ experience in regulatory medical writing, 6 of which should be in writing submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.) in the area of oncology; The incumbent must have extensive experience in developing clinical documents in support of regulatory submissions globally (ie multiple regions) in the area of oncology; The incumbent must have relevant experience in managing and mentoring medical writers and must have successfully led medical writing teams developing the clinical sections of CTD dossiers; The incumbent must have a thorough knowledge of the pharmaceutical industry, including understanding the oncology drug development process and associated documents and regulations; Specific knowledge of the clinical study protocol and clinical study report development process, regulatory and drug safety requirements, and clinical data management and statistical processes/functions is required; The incumbent must have an in depth understanding of all applicable scientific and regulatory guidance, standards and requirements pertaining to regulatory medical writing in oncology worldwide (e.g. ICH, FDA, EMA, CFDA); The incumbent must also have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions; The incumbent must demonstrate outstanding communication skills (both written and verbal) required to articulate concepts and ideas; The incumbent must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the SBU Oncology organization; High affinity to internal and external collaboration, including commitment towards external visibility is required. Preferred Qualifications: PhD is highly preferred. Country: United States State: New Jersey Location: Whippany Reference Code: 66676 Functional Area: Clinical Development & Operations Entry Level : Professional Share Facebook Twitter E-Mail Linkedin Pinterest Apply Online Job Search Career level Career Level Student (m/f/d) Job Starter (m/f/d) Professional (m/f/d) Functional area Functional Area Accounting Biochemical R&D Biological R&D Biotechnology R&D Chemical R&D Clinical Development & Operations Commercial & Sales Communications & Public Affairs Computational Science, Data Science & Statistics Controlling Customer Operations and Support Engineering & Technology General Administration & Corporate Services General Management & Business Consulting Human Resources Information Technology Law, Patents, Compliance & Insurances Market Access Marketing Medical Affairs & Pharmacovigilance Procurement Production&Manufacturing Quality R&D other jobs Regulatory Affairs Supply Chain Management Sustainability, Health, Safety, Environment country Country Argentina Australia Austria Bahrain Belgium Bolivia Brazil Bulgaria Canada Chile China Colombia Costa Rica Croatia Cyprus Czech Republic Denmark Dominican Republic Ecuador Egypt El Salvador Estonia Finland France Germany Greece Guatemala Honduras Hungary India Indonesia Iraq Ireland Israel Italy Japan Jordan Kuwait Latvia Lebanon Libya Lithuania Mexico Morocco Netherlands New Zealand Nicaragua Norway Oman Pakistan Palestine Panama Paraguay Peru Philippines Poland Qatar Romania Russia Saudi Arabia Serbia Slovakia Slovenia South Africa South Korea Spain Sudan Sweden Switzerland Syria Thailand Turkey Ukraine United Arab Emirates United Kingdom United States Uruguay Venezuela Vietnam Yemen Location All Location in Aberdeen Abidjan Akron Albuquerque Alcalá de Henares (Madrid) Altai Amsterdam Andhra Pradesh Ankeny AnShan Antwerp Arequipa Arusha Ashton Autry-le-Châtel BaiCheng Bakersfield Baltimore Bangalore, Karnataka BaoTou Barcelona Basel Basel Beaman BeiJing Belford Roxo Belo Horizonte BenXi Bergkamen Bergschenhoek Berkeley Berlin Billings Birmingham Bitterfeld-Wolfen Boise Boissay Boone Boston Brooks Brussel Brussels Bucharest Budapest Burscheid Calgary Camaçari Cambridge Cambridge Campinas CangZhou Capital Federal Carman Carmel Carnaxide Carnaxide Cartagena (Murcia) Cary Centralia Champaign ChangChun ChangDe ChangSha ChangZhou ChengDu ChenZhou Chesterfield Cheyenne Chicago ChiFeng ChongQing ChuZhou Ciudad de México Clarion Cleveland Collinsville Colón Comitan Constantine Cranbrook Creve Coeur Cristalina Cumberland Curitiba DaLi DaLian Dallas DanDong DaQing Darmstadt Davis Deforest Diegem Diegem DongGuan Dormagen Dublin Ecatepec Edmonton Eloy Enkhuizen Farmos Filago Filer Fort Worth FoShan Fourways Frankfurt a.M. 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