Medical Writer (AMCP Dossier Writing/Oncology)

Location: Onsite Preferred but open to Remote (Manager sits in IL so CST time zone preferred) Contract: 6 months - based on performance and business needs Medical writing exp Main focus is writing AMCP dossiers Academic and research exp will be considered (Combination is fine)

• Background in regulatory submissions is not needed
• Pharma or CRO industry exp needed
• Good communication and interpersonal skills
• Clinical research knowledge needed
• 5 yrs of medical writing exp
• Product monographs, Documents
• Work cross functionally with diff groups(HEOR, science director, physician etc)
• Writing abstract, poster, slide sets, dossiers and other documents
• Good understanding of economic information (cost effective analysis,
• Advance science medical technology degree, nursing degree
• Certification in oncology (Pharm D will that certification)
• Masters degree will work

What are the top 5 skills/requirements this person is required have?

• Required Skill 1: Innovative writing with extensive knowledge and understanding of clinical research. Able to succinctly summarize complex scientific publications and translate science to a lay audience.
• Required Skill 2: Excellent verbal and written communication skills in addition to good interpersonal skills (i.e., build relationships with cross-functional colleagues). Is accountable and exhibits client leadership attributes.
• Required Skill 3: Proficient in the use of Office 365 software such as PPT, Word, Excel, etc.
• Required Skill 4: Proficient in the use of graphics software, including Adobe Illustrator for Medical Writer II. Preferred for Medical Writer III but not required.
• Required Skill 5: Accurate in work, efficient, and contributes to process improvement.

What years of experience, education, and/or certification is required?

• PhD in Sciences or Technology, PharmD, or MD for Medical Writer III with 5+ years of experience in medical or scientific writing.

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Should have evidence of publications in peer-reviewed journals as first author and/or has written AMCP dossiers.
• Writers with prior experience in AMCP Format and AMCP Dossiers. Certification in oncology.

What is the environment that this person will be working in (i.e. group setting vs individual role)?

• Individual contributor with cross functional collaboration.

Purpose:

• Write and edit high-quality, medically relevant AMCP dossiers for assigned therapeutics areas or assets to fulfill medical, scientific, and health economic objectives.
• Ensure successful preparation of high quality submission-ready documents and effective implementation of writing process and serve as AMCP dossier writing expert for the department.

Responsibilities:

• Responsible for but not limited to: developing, editing and managing the production of AMCP Dossiers and scientific presentations for payers
• Collaborate with therapeutic area leads to incorporate TA strategies, scientific platforms, value messages into AMCP dossier
• Collaborate with Global Medical Information to develop and/or edit responses to address specific unsolicited payer and health care provider requests for health outcome information
• Analyze and interpret scientific data to update or develop comprehensive, balanced, credible and accurate documents that comply with applicable laws, regulations, guidance’s and policies and procedures, and are used to appropriately respond to inquiries from payers and health care providers
• Provide medical writing support for multiple assets within a therapeutic area(s)
• Understand, assimilate, and interpret sources of information with appropriate guidance/direction from team members. Interpret and explain data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables, and verify the results are consistent with study data. Perform literature searches for drafting AMCP dossiers
• Manages and prioritizes multiple projects, provides solutions to complex problems, and delivers complete and accurate information within deadlines
• Identify and propose solutions to resolve issues and questions arising during the writing/review process, including resolution or elevation as appropriate
• Maintains awareness of current industry practices that pertain to Corporate Policies and Procedures. Must continually train/be compliant with all current industry and company requirements
• Complies with the reporting of adverse effects and product complaints to Pharmacovigilance and Surveillance

Qualifications:

• Pharm. D., Ph.D., or equivalent
• Experience in the development of AMCP dossiers and documents related to outcomes research; understanding of model documents (templates) and how to use them correctly
• 3-5 years relevant industry work experience; recognized expert in medical communications and medical writing; extensive, proven experience and skill in writing high-quality, evidence-based scientific documents
• Proficient in managed care or access; previous experience in formulary or evidence-based evidence writing, review and assessments, and knowledge in evidence-based healthcare decision-making processes
• Ability to assimilate and interpret scientific content, and translate information for appropriate audience
• HEOR technical training is a plus
• Working knowledge of statistical concepts and techniques
• Highly proficient in the use of Microsoft WORD and POWERPOINT

Job Type: Contract Pay: $60.00 - $62.00 per hour Expected hours: 40 per week Education:

• Master's (Preferred)

Experience:

• AMCP dossier writing expert : 5 years (Preferred)
• oncology background: 5 years (Preferred)
• Writing abstract, poster, slide sets, dossiers etc: 5 years (Preferred)
• medical or scientific writing.: 5 years (Preferred)
• Pharma or biotech industry: 5 years (Preferred)

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