Medical Writing Strategist Oncology

Employment Type

: Full-Time

Industry

: Miscellaneous



Medical Writing Strategist Oncology

YOUR TASKS AND RESPONSIBILITIES

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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;
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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;
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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;
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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;
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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;
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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;
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He/She provides consultation and mentors associate submission and submission medical writers;
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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;
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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:

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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;
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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;
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The incumbent must have extensive experience in developing clinical documents in support of regulatory submissions globally (ie multiple regions) in the area of oncology;
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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;
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The incumbent must have a thorough knowledge of the pharmaceutical industry, including understanding the oncology drug development process and associated documents and regulations;
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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;
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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);
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The incumbent must also have an excellent working knowledge of current electronic authoring, document management and electronic regulatory submissions;
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The incumbent must demonstrate outstanding communication skills (both written and verbal) required to articulate concepts and ideas;
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The incumbent must be diplomatic, persuasive and be able to establish rapport with all key functional leaders and experts in the SBU Oncology organization;
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High affinity to internal and external collaboration, including commitment towards external visibility is required.

Preferred Qualifications:

- PhD is highly preferred.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

If you meet the requirements of this unique opportunity, and you have the 'Passion to Innovate' and the 'Power to Change', we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice.

Division: Pharmaceuticals Reference Code 66676

Functional Area: Clinical Development & Operations Location: United States : New Jersey : Whippany

Employment Type: Regular Position Grade: VS 3

Contact Us

AddressTelephoneE-Mail

Pittsburgh, PA +1 ************, option #5 ******************

15205-9741

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