Senior Medical Information Writer

THE POSITION:

At EVERSANA our integrated life sciences compliance team is taking a leading role in helping some of the most scientifically advanced Biopharma and research companies around the world to innovate novel therapies for rare ultra-rare and a range of critical therapeutic areas including Oncology Neurology Immuno-oncology Immunology etc. This role is within the EVERSANA Compliance team reporting directly to the Director Medical Content Development and Medical Review. This person will also collaborate very closely with other team members within the EVERSANA Compliance Business Unit (Medical Information (MI) and Medical Affairs).

This position will support various types of clients including pharmaceutical biotechnology medical devices digital therapeutics and over-the-counter companies. This position is responsible for MI content development-related client engagements.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
Our employees are tasked with delivering excellent business results through the efforts of their teams.  These results are achieved by:

• Develop review and maintain scientifically accurate evidence-based Medical Information (MI) content including Scientific Response Documents (SRDs) Global Response Documents (GRDs) Customized Response Documents (CRDs) FAQs cover letters training materials and other medical information and scientific communication resources.
• Independently manage the end-to-end MI content development lifecycle including literature searches synthesis of evidence content authoring incorporation of stakeholder feedback document finalization and coordination of Medical Legal and Regulatory (MLR) review processes.
• Serve as the primary content owner within document management systems (Veeva Vault Systems) ensuring accurate document upload lifecycle management version control reference linking annotation and compliance with documentation standards and regulatory requirements.
• Conduct quality control and peer reviews scientific data verification and reference validation to ensure accuracy consistency scientific rigor and compliance of MI deliverables.
• Manage translation requests and coordinate with external translation vendors to ensure timely delivery of high-quality scientifically accurate and locally compliant medical information materials.
• Participate in client-facing and internal meetings to provide scientific expertise project updates and recommendations on MI content and communication strategies.
• Support the development review and continuous enhancement of Standard Operating Procedures (SOPs) work instructions templates style guides quality checklists and process documentation to drive operational excellence and compliance.
• Ensure all medical information materials are scientifically balanced evidence-based compliant with applicable regulatory and company requirements and aligned with industry best practices.
• Responsible for proactively flagging and managing any quality issues and ensure timely corrective and preventive actions
• Stays knowledgeable of industry best practices and supports leadership team in evaluating and implementing new technologies and procedures to improve operational efficiency and quality of materials developed.
• Works collaboratively with other medical writers and creative teams across EVERSANA.
• Demonstrate a commitment to diversity equity and inclusion through continuous development modeling inclusive behaviors and proactively managing bias.
• All other duties as assigned.

EXPECTATIONS OF THE JOB:

• Responsible for delivering CLIENT DELIGHT
• Responsible for working collaboratively with EVERSANA medical information and medical affairs team and taking directions and feedback from management and clients
• Responsible for ensuring management and compliance with industry standards and codes

of practice

• Able to work independently to develop high-quality scientifically accurate strategically aligned ethical and compliant medical content
• Responsible to proactively flag and manage any quality issues and ensure timely

corrective and preventive actions

• Hours: Able to work full time and be flexible with work scheduling as required by clients and management. (40 hours per week 5 days of the week)

MINIMUM KNOWLEDGE SKILLS AND ABILITIES:

The requirements listed below are representative of the experience education knowledge skill and/or abilities required.

• Education: Minimum bachelors degree in scientific discipline or healthcare; Masters PhD or PharmD preferred
• Experience: Minimum of 2 years of MI writing and medical content development experience
• Exceptional communication skills include written oral interpersonal and presentation skills including the ability to independently interpret and summarize complex results.
• Ability to effectively interface with all levels of management and staff and to succeed in a matrix team setting while meetings or exceeding timelines.
• Familiarity with AMA Style guide as well as an understanding of clinical research principles and applied statistics. Familiarity with International Committee of Medical Journal Editors (ICMJE) Good Publication Practices (GPP) and other medical publishing guidelines (e.g. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Consolidated Standards of Reporting Trials (CONSORT) etc.
• Proficient editing skills along with expertise in Microsoft Office Acrobat and other applications.
• Experience conducting literature searches and working with tools such as PubMed Ovid Embase etc.
• Experience working with reference management and citation software (e.g. EndNote Mendeley Citavi etc.)
• Strong understanding of regulatory requirements and best practices in relationship to Medical Information Medical Affairs and promotional and non-promotional materials review.
• Excellent project management skills and proven track record of being results driven; ability to manage
• Ability to conceptualize design and deliver best in class solutions
• Highly principled proves to be a professional of unquestionable integrity credibility and character who demonstrates high moral and ethical behavior
• Collaboration Ability to work cross functionally across EVERSANA business units and with various clients including leadership and various departments and functions of our clients
• Agile learning Ability to support and learn about multiple disease states and therapeutic areas

Qualifications :

• Education: PharmD (or M. Pharm or M.S. Pharm) PhD or MD
• Experience: Strong expertise in MI content development and scientific writing with a track record of delivering accurate evidence-based and compliant medical communications.
• Broad therapeutic area experience with the ability to effectively manage diverse product portfolios and complex scientific content.
• Proficiency in Veeva Vault System including document management workflow administration content promotion processes and MLR review support.

Additional Information :

All your information will be kept confidential according to EEO guidelines.

Our team is aware of recent fraudulent job offers in the market misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites unsolicited e-mails or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA.

From EVERSANAs inception Diversity Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer and our employees are people with different strengths experiences and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity but also age disability status veteran status sexual orientation religion and many other parts of ones identity. All of our employees points of view are key to our success and inclusion is everyones responsibility.

Follow us on LinkedIn Twitter

Remote Work :

No

Employment Type :

Full-time