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This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Lake Forest, Illinois
job type: Contract
salary: $45.00 - 52.07 per hour
work hours: 9 to 5
- Serve as medical writing lead on scientific publications. Provide writing/editing expertise, ensuring successful preparation of high-quality submission/presentation-ready documents at the direction of publication authors for multiple assets within a therapeutic area(s). Proficiently learn and apply TA knowledge, rapidly understand and effectively incorporate new/complex information into publication projects. Perform/interpret literature searches, as needed, for drafting publication content.
- Execute all activities related to the preparation of scientific publications (ie, clinical manuscripts, abstracts, posters, and oral presentations). Coordinate the review, approval, and other applicable activities related to the development of scientific publication projects. Maintain expert knowledge of US and international requirements and guidance associated with scientific publications.
- Provide direction and guidance to external medical writers regarding publication projects, ensuring a high-quality and timely work product, and adherence to Publication Policy and associated Procedures. Present information to appropriate individuals in a concise, clear, and objective manner. Provide budget assistance by managing contracts and/or expenses for assigned projects.
- Establish, maintain, and expand business relationships with staff from functional areas collaborating on publication projects, including external experts (physicians, other health care professionals) and staff from other functions (Clinical, Medical Affairs, Statistics, Data Management, PK) to ensure accurate and timely completion/delivery of information, including addressing conflicting demands and review of scientific publications.
- Contribute to Publication Team Meetings and to publication strategy/brainstorming discussions, including proposing publication ideas. Contribute to monitoring TA/competitive environment, and share relevant information with department colleagues and other publication stakeholders. Serve as a department representative and medical writing expert on product teams. Communicate deliverables needed, writing process, and timelines to team members.
- Understand, assimilate, and productively interpret sources of information, with appropriate guidance/direction from authors and product team members. Interpret, convert and explain data generated from a variety of sources. Explain data in manner consistent with the target audience(s) and journal/congress requirements. Understand/comply with format requirements per journal/congress guidelines, and follow applicable company Publication Policy and Procedures.
- Independently resolve issues and questions arising during the writing/review process. Act as Subject Matter Expert for assigned teams regarding publications-related computer-based technologies (eg, Datavision).
- Mentor and provide guidance to medical writers. Provide writing- and process-related mentorship/training to new medical writers across TAs. Review and provide feedback on medical writing projects of medical writers in assigned TAs, as designated by manager.
- Participate in department initiatives/activities that impact medical publishing practices/processes. Recommend, lead, and implement practice/process improvements. Conduct review of publication projects for quality and alignment with medical/scientific objectives, as assigned. Ensure project information in publication records and resourcing tools are accurate and up-to-date.
- Responsible for compliance with applicable Corporate Policies and procedures. Must continually train/be compliant with all current industry and company requirements as they relate to scientific publications.
- Minimum of Bachelor's Degree required. PhD, PharmD, Master's Degree preferred. Relevant professional certification/credential (eg, CMPP, AMWA) is a plus.
- 4 years of medical/scientific writing experience in the pharmaceutical/health care industry, academia, or related experience (eg, medical communication agency, clinical/scientific research) required.
- Expert knowledge of US and international regulations, requirements, and guidances associated with scientific publications, and ability to advise teams regarding compliance with regulations, requirements, and guidances.
- High-level content writing experience, as well as experience with all types of clinical publications required.
- Expert in assimilation and interpretation of scientific content with adeptness in ability to translate for appropriate audience.
- Working knowledge of statistical concepts and techniques required.
- Excellent written and oral communication skills. Superior attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy.
- Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment. Microsoft Office and Internet navigation proficiencies essential. Working knowledge of Datavision publication management system is a plus.
- Extensive experience in working with collaborative, cross-functional teams, including project management experience. Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher performance. Excellent business communication skills.
- Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality. Learns fast, grasps the essence and can change the course quickly where indicated. Raises the bar and is never satisfied with the status quo.
skills: Editing, GCP (Good Clinical Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.