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We are seeking a Regulatory Affairs Consultant to join our Clinical and Regulatory department. As our Consultant, you will play the important role of evaluating and analyzing scientific information to support a variety of projects within the organization, including client-related projects and marketing initiatives. You will be expected to be extremely familiar with scientific data and nomenclature and be able to effectively communicate scientific principles to non-scientists, scientists, and physicians.
Key responsibilities include:
- Scientific Summary and Analysis: Review scientific studies and data relevant to a particular scientific issue and provide meaningful written and/or oral critical analysis and integration as to how it affects the client objectives.
- Client Interaction: Provide oral and written communication with clients to convey project status, interim reports, and final project deliverables.
- Budget Preparation: Provide budget estimates for project proposals.
- Management and Oversight: Provide direction for Researchers and Managers on project work.
- Review and Revise Work Product: Review written work product for clarity and style and revise as necessary.
- Project/Business Expanstion: Possess ability to identify opportunities to expand existing client projects into larger and more profitable jobs.
We are seeking an advanced degree life-sciences professional to serve as a Medical Writer within our Medical Strategy and Communications team, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges.
The Medical Writer will develop high-quality, technically accurate content for a wide range of medical communications projects and deliverables including clinical publications, (manuscripts and abstracts), slide decks, scientific platforms, symposia, advisory boards, and training materials. The Medical Writer will be responsible for the editorial component of assigned projects including background research, literature searches, reference identification, writing and revisions, and preparation of tables and figures.
In this role, the Medical Writer must have a deep understanding of scientific data and excellent writing and communication skills to develop a narrative that resonates with the target audience. This role requires the ability to work independently and as part of a team, in collaboration with cross-functional teams and developing content under strict deadlines.
The Account Manager will ensure successful management of accounts on a day to day basis from the execution to completion of client projects. As the Account Manager, you serve as the primary client contact and will be responsible for facilitating and tracking projects and financial deliverables, and work closely with the project team members to communicate client needs and expectations, ensure timelines are developing, and potential issues are identified and resolved.
Additional responsibilties include:
- Prepare for and lead internal and client status meetings including meeting materials
- Understand and ensure the team follows all client required standard operating procedures and requirements
- Alert other internal departments of resourcing needs
- Draft scope of work and budgets based on client direction and ensure internal alignment and approval before submitting to client for review/approval/processing
- Monitor and adhere to approved budgets
- Report budget changes (i.e. change in scope that may lead to overage) to the client in a timely manner
- Maintain accurate financial spreadsheets to support internal and client needs
- Submit invoices, accruals, etc. in a timely manner consistent with both internal and client directed SOPs
- Prepare for and is accountable for actions discussed in monthly revenue and forecasting meetings
- Maintain accurate records within client chosen publication technology program (i.e. Datavision, PubSTRAT, PubsHub, JPUBS, VivaVault, etc)
- Provide timely and accurate project status updates and client requested reports (i.e. bibliography, TASC, icon charts, etc)
- Work efficiently with the publication technology team in a proactive and organized manner consistent with optimizing use of the publication technology resource
We are seeking life sciences professional to join our Clarion consulting team. As Manager, you play a key role in both project execution and case team leadership by leveraging your experience and expertise to deliver high-quality work while providing direction to case teams and fostering client relationships. As a member of the management team, you will also help to shape the strategic direction of the firm by supporting and eventually leading business development efforts and making significant contributions to internal initiatives.
Primary responsibilities include:
- Oversee day-to-day activities of multiple, concurrent project teams across therapeutic areas, value chains, and project types, including guiding the work of others and fostering a team environment
- Structure overall project workplan and resource allocation, involving both qualitative and quantitative research and analysis
- Act as a valued thought leader and primary point of contact with senior-level clients
- Communicate insights and recommendations to clients, working directly with them to shape their thinking on case and broader organizational issues
- Support business development efforts and initiatives, including capability presentations and proposal writing
- Make significant contributions to internal firm initiatives to continuously improve efficiency, quality of work, and/or overall firm culture
- Mentor and coach junior staff in formal and informal situations
We are seeking an advanced degree life sciences professional to join our Medical Communications team and serve as the Associate Scientific Director. This position falls within our wider Medical Strategy and Communications division, which serves our clients by mobilizing our scientific knowledge to evaluate the therapeutic landscape, interpret the data, and create compelling content and narratives to guide their medical strategy and through regulatory challenges.
The Associate Scientific Director will oversee the development of technically accurate and high-quality deliverables on assigned accounts while managing and mentoring a team of Medical Writers. This role requires a balanced ability to:
- Think strategically
- Review and edit deliverables, having final sign-off authority for projects on all assigned accounts
- Act as the primary point of contact for communicating with authors and clients on medical/scientific content
- Serves as a mentor for less experienced Medical colleagues
- Meet project deadlines without compromising editorial quality or technical accuracy
- Contribute to client presentations and proposals, providing scientific input and therapeutic area expertise
- Work simultaneously on multiple projects, sometimes relating to multiple products in various therapeutic areas
We are seeking a talented, scientifically strong and entrepreneurial spirited life sciences professional with some previous experience to join our Consulting team with our Medical Affairs division. As part of our team, the Associate Consultant will play an important role working with our clients and Medical Affairs leaders from pharmaceutical, biotechnology, medical device, drug delivery and diagnostic industries.
Our environment provides Associate Consultants with exposure to a wide variety of scientific and medical issues faced by the life sciences industry. Lumanity’s diverse consulting assignments include therapeutic area strategy development, product opportunity assessments, development of training programs, due diligence, publication and scientific communication strategy, and new product launch planning. Our clients are domestic and worldwide and range in size from start-up companies to global organizations.
In this role, the Associate Consultant will support the implementation of multiple projects from initiation through to delivery by leading specific pieces of the projects such as conducting research and translating clinical study data for utilization in reports and communications tools, facilitation of client workshops, and creation of impactful and concise client presentations.
This is a perfect opportunity for Associate Consultants to develop their skills through formal and informal training, as well as receiving mentorship to build knowledge of the pharmaceutical industry and Medical Affairs.
We are seeking an advanced degree life sciences professional to join our Medical Communications team and serve as the Scientific Director (or Senior Scientific Director depending on experience). This position falls within our wider Medical Strategy and Communications division, which serves our clients by mobilizing our scientific knowledge to interpret the data and create compelling narratives to guide their medical strategy and through regulatory challenges.
The Scientific Director will serve as a strategic partner to clients and oversee the development of technically accurate and high-quality deliverables on assigned accounts while managing and mentoring a team of Medical Writers. This role will lead the development of and contribute to clients’ overall plans by providing input to and developing strategically-focused communication and publication plans, and foster opportunities for expanded client interaction and engagement.
We are seeking a Principal to join our leadership team and provide people, project, and business development leadership. As a Principal, you will use expertise in strategic marketing to identify client needs, address client strategy challenges, and serve as a trusted advisor to a range of clients. This role will design and lead complex strategic projects, and coach, manage, and support the project team to deliver high quality outcomes, while enhancing your team’s skills and supporting individual development. The Principal will lead significant business development activities, nurturing and strengthening existing relationships, while pursuing new business.
Primary responsibilities include:
- Provide proactive executive leadership to case teams to support client engagement and delivery
- Identify growth opportunities with existing clients
- Act as a valued thought leader to support strategic discussions with senior-level clients beyond the scope of case work and specific business development discussions
- Support the development of long-term growth plans; identifying potential business categories and growth strategies
- Lead the scoping, development and delivery of proposals for clients
- Actively build and leverage a professional network
- Support lead/referral generation and transitions into leads with both current accounts and new account development
- Develop and maintain capability communication materials to offer deep insights, innovative solutions, and impactful product offerings
- Help to advance internal thought leadership across particular functional or therapeutic areas within life sciences
- Provide a steady stream of perspectives and insight updates on the latest news, trends, and direction of key industry topics to key members of the Clarion team
- Mentor and coach junior staff, as well as encourage engagement with firm development
- Participate in the ongoing management and development of staff
- Help to establish the strategic direction of the firm
- Engage a significant portion of time in firm building responsibilities including recruiting, marketing, knowledge management, DEI, and others
- Be a positive and active contributor to management meeting discussions
- Effective collaboration with experts across business practice areas within the broad Lumanity organization, leveraging access to broad capabilities of the organization to best service our collective clients and provide learning and growth opportunities for our team members