Medical Affairs Manager

Company Description

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! 

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. 

Job Description

THE POSITION:

Medical Information is a critically important customer-facing function that supports the safe and effective use of pharmaceutical, biopharmaceutical, medical device, and digital therapeutic products by providing timely, scientifically balanced, evidence-based, non-promotional information in response to unsolicited requests from healthcare professionals, patients, caregivers, and payers. 

An important aspect of medical information is developing, managing, and providing impactful medical response documents. The Medical Affairs Manager is responsible for medical content development-related client engagements and ensuring the accuracy, quality, and compliance of the medical review of promotional and non-promotional materials adhering to local regulations, legislation, European regulatory standards, and best practices (e.g., IFPMA-Code of Practice, EFPIA-Code of Practice, AMG and HWG) while following ethical standards. This role requires excellent communication skills (both verbal and written).

Must be legally eligible to work in the United Kingdom.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

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

Medical Content Development

• Plays an essential role in supporting the Global Medical Information / Medical Content Development Team on content development-related engagements for clients who require medical content development and management services.
• Establishing project plan (in partnership with project management when applicable)
• Accountable for the client deliverables, including timeliness and quality
• Coordinating and participating in meetings with clients, agendas, action items, follow-up
• Responsible for providing direction, coordinating, communicating, and working with assigned writers, graphic designers, project management
• Responsible for writing and developing materials, in addition to performing quality assurance of assigned writer’s and graphic designers’ deliverables
• Works with EVERSANA and/or client-provided document management technology platforms (i.e., Veeva PromoMats / MedComms, etc.) as content owner and attending MLR meetings when appropriate
• If assigned, may attend cross-functional team meetings (e.g., complete commercialization meetings)
• All other duties as assigned

Medical Review

• For assigned clients and products, act as a scientifically responsible person and Final Medical Signatory medical reviewer (e.g., Drug Information Officer, Pharmacist Responsible, Scientific Responsible Person, etc.) for Germany, Spain, Italy, France, or the UK where promotional/non-promotional materials will be disseminated as per the relevant applicable codes (e.g., IFPMA and EFPIA Codes of practice, ABPI, etc.).
• Contribute to the review and approval of country-specific promotional and non-promotional materials in collaboration with the client’s Medical Affairs colleagues for scientific accuracy and in compliance with International and Local regulations and guidelines, as well as the client’s internal policies.
• Review promotional/non-promotional materials for content and accuracy; participate in review committee/strategic meetings to provide inputs on the product, therapy area, reference substantiation, alignment to brand messages, etc.; review and approve data on file packets; and manage planning and prioritization of reviews.
• Ensure that data are scientifically accurate, contextually correct, editorially accurate, and are presented in a fair/scientifically balanced manner with minimal supervision and in a timely manner:
• Ensures scientific accuracy, relevance, and completeness of data
• Ensures claims and data are clinically and statistically relevant and presented in a scientifically balanced manner (not false or misleading)
• Ensures that claims are adequately supported by data
• Determines acceptability of references
• Advises on whether claims are consistent with the approved label
• Ensure that the piece is relevant and of utility for the target audience.
• Identify, communicate, and resolve issues impacting timelines.
• May work collaboratively within Medical, Legal, and Regulatory (MLR) review committee meetings providing support and direction to material developers and owners.
• May submit promotional materials to the regulatory authorities when applicable.
• Demonstrate and maintain thorough expertise and understanding of assigned products, therapeutic areas, applicable laws, regulations, guidance documents, industry standards, publication requirements, and best practices regarding the review and approval of promotional and non-promotional materials.
• May participate in MLR committee and applicable client meetings.
• Experience working with review and approval systems (e.g. Veeva).

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

EXPECTATIONS OF THE JOB:

• Responsible to deliver CLIENT DELIGHT
• Responsible for working collaboratively with EVERSANA medical information and medical affairs team and taking direction and feedback from management and clients
• Maintain detailed and organized records to ensure regulatory compliance. 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 for proactively flagging and managing any quality issues, and ensuring timely corrective and preventive actions
• Responsible for working collaboratively with EVERSANA medical information and medical affairs teams and taking direction and feedback from EVERSANA management and clients.
• Able to work independently to develop high-quality, scientifically accurate, strategically aligned, ethical medical content.
• Responsible for proactively flagging and managing any quality issues and ensuring timely corrective and preventive actions are implemented.
• Travel This position may require business travel and will need to be able to travel up to approximately 10-15%.
• Hours: Able to work full-time and be flexible with work scheduling as required by clients and management.

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

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

• Education: Pharmacy, Medical Doctor, or PhD degree in Life Sciences or healthcare or equivalent.
• Experience and/or Training:
• A minimum of 2-year(s) experience in the pharmaceutical industry or Medical Information / Medical Communications service provider and medical review experience. Experience developing global medical information materials, e.g., scientific response documents (SRDs), frequently asked questions (FAQs), custom response documents (CRDs), etc.
• Experience performing medical reviews of promotional and non-promotional materials and has had signatory medical review experience
• Strong understanding of regulatory requirements and best practices in relationship to Medical Information, Medical Affairs, and promotional and non-promotional materials review
• Exceptional written, oral, interpersonal, and presentation skills including the ability to independently interpret and summarize complex results. Ability to establish credibility with a variety of audiences; especially with clients
• Ability to effectively interface with all levels of management and staff and to succeed in a matrix team setting while meeting or exceeding timelines.
• 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.)
• Experience in review and approval platforms (e.g., Veeva)
• Excellent project management skills and proven track record of being results-driven
• Ability to conceptualize, design, and deliver best-in-class solutions.

PREFERRED QUALIFICATIONS:

• Education: A Pharm.D. or Pharm.M or a Degree in Medicine or PhD is preferred. Additionally, 2+ years of experience as a Medical Reviewer of promotional and non-promotional materials. Prior experience in Medical Affairs / Medical Information / Medical Communications within the Biotechnology or Pharmaceutical Industry.
• Experience: Medical Information, Medical Communications, Medical Writing, Medical Review, and Medical Affairs; experience developing medical content, especially Medical Information materials, for both new product launches and for updating and managing current materials; experience working across multiple therapeutic areas. Subject Matter Expert (SME) for Medical Affairs and maintain knowledge of local and international industry standards, best practices, and applicable laws and regulations. Country-specific final signatory designation is a plus.
• Communication Skills: Possesses the ability to develop and articulate ideas and information that generate understanding and create a climate that motivates and encourages others to participate. Highly fluent in English, both written and verbal, plus one or more other European languages (i.e., German, French, Italian, Spanish) to the Common European Framework level B2, C1, or C2 is desired.
• Analytical Thinking / Critical Thinking: Ability to analyze, digest, and interpret complex scientific information and data; evaluate promotional materials, and ensure compliance.
• Project Management: Ability to develop project plans and execute the project plan, both working individually and with client(s), other medical content development team members, the medical information contact center team and leadership team, and/or the MLR team.
• Results Driven: Proven track record of executing and delivering results.
• Innovator: Transforms creative ideas into original solutions that positively impact client delight and the company’s performance.
• Highly Principled: Proves to be a professional of unquestionable integrity, credibility, and character who demonstrates high moral and ethical behavior.
• Client Management: Ability to manage, coordinate, and oversee relationships and projects with assigned client(s).

Additional Information

Patient Minded I act with the patient’s best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and hold myself accountable.

Embrace Diversity I create an environment of awareness and respect.

Grow Talent I own my development and invest in the development of others. 

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful, and timely dialogue.

Always Innovate I am bold and creative in everything I do.

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 EVERSANA’s 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 one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone’s responsibility.

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