Business Development Operations - Hyderabad - Imaging Endpoints

Description

Imaging Endpoints (IE) is an Imaging Technology and Imaging Clinical Research Organization (iCRO). We are passionately focused on our vision to Connect Imaging to the CureTM. Everything we do is aligned with this singular purpose. We work every day excited to advance imaging science, technology, and services to bring curative technologies to humankind. We have supported many of the most impactful new drug approvals in oncology, and we are seeking the most talented individuals globally that are passionate in their desire to assist us in our mission to customize each clinical trial's imaging to optimize the opportunity to demonstrate efficacy.

Imaging Endpoints is based in Scottsdale, Arizona, with offices in Cambridge, Massachusetts; London, UK; Leiden, Netherlands; Basel, Switzerland; Hyderabad, India and Shanghai, China. We are an affiliate of HonorHealth, one of the largest healthcare systems nationally, and Scottsdale Medical Imaging Limited (SMIL/RadPartners), the largest private radiology group in the United States. We are recognized as the world's largest and most preeminent iCRO in oncology.

Under the direction of Business Development Operations, the Business Development Operations –

Scientific Writing Manager is primarily responsible for the proposal, contract, and change order processes within IE and shall coordinate with Business Development, Operations, Medical & Scientific Affairs, Finance, and Compliance & Regulatory Affairs to prepare, review, and negotiate proposals, contracts and change orders. This position will interact with clients, vendors, and other stakeholders and collaborate with internal staff across all departments.

BUSINESS DEVELOPMENT OPERATIONS - SCIENTIFIC WRITING MANAGER

RESPONSIBILITIES

• Manage the coordination and development of business proposals (request for proposal/request for information: RFP/RFI) and contracts for prospects and clients.
• Coordinate with the proposal team to optimize proposal design by identifying and clarifying opportunities and needs described in RFPs and associated documentation. Integrate IE experience, key differentiators, and other industry best practices into proposals and presentations.
• Identify and communicate risks associated with proposals and contracts.
• Meet proposal deadlines by establishing target dates and identify priorities involved in information gathering, writing, review, and finalization.
• Preparation of quality assumption tables (ATs) and budgets for the proposal and align the AT, deliverables, and budget together within specified timelines to meet the needs of the clients and/or as directed by IE Management team.
• Participate in or lead key internal and external meetings related to proposals and contracts as applicable.
• Conduct verbal and/or written follow-up after the submission of proposals as needed and/or directed by IE Management team. Communicate to the IE team the outcome of the negotiations/proposals focusing on conveying the expectations for each group, i.e., critical timeframes and scope of work.
• Develop and manage business development efforts by.
• Responsible for consistently nurturing agreed upon high value targets, as applicable and/or as directed by IE Management team.
• Represent Imaging Endpoints in conferences and meetings with clients and prospective clients, if needed.
• Interact with, build relationships with and support sponsors and vendors as applicable and/or as directed by IE Management team.
• Preparation and adherence of contract amendments and change orders, including alignment with imaging trial documents i.e. Image Review Charter, Imaging Manual, Data Transmittal Forms, and other study specific documents.
• Ensure contract amendments and change orders are complete, current, and have been tracked and stored appropriately.
• Assist with process improvements to the Contract amendments and change orders process.
• Monitor and improve turnaround times for the delivery of amendments and change orders to sponsor contacts
• Identify out of scope requests and work with appropriate team(s) to revise the work order to meet changing needs and requirements.
• Participate in providing details required for RFIs upon request.
• Work closely with the Head of Project Management and Imaging Operations departments to assist with the SOP/WI updates as required based on the new processes/gaps that are identified on an on-going basis.
• Perform other duties as assigned by the supervisor.

EDUCATION AND EXPERIENCE

• 3+ years of experience in the pharmaceutical or a regulated industry.
• 2+ years of experience in medical imaging preferred.
• 2+ years in technical writing, proposal development preferred.
• Bachelor's degree in English, Journalism, Marketing, Communications, Business, Computer
• Science/MIS, Science, Law, or related area.
• Knowledge and understanding of 21CFR Part 11, Good Clinical Practices (ICH E6 GCP), Good
• Documentation Practices (GDP).
• Imaging Core Lab and/or Contract Research Organization experience preferred.

SKILLS

• Advanced user of Microsoft Word, Excel, and Power Point.
• Excellent oral communication skills over the phone and in person.
• Excellent written communication skills.
• Solid research, writing, proofing, formatting, grammatical, and editing skills.
• Superior attention to detail, particularly in written documentation.
• Ability to motivate others and facilitate a positive work environment.
• Excellent organization, administrative, and time management skills.
• Ability to meet aggressive timelines/deadlines; ability to work weekends and holidays to meet
• critical deadlines.
• Strong commitment to performing and producing at the highest level of quality.
• Service oriented approach to work; flexible and proactive towards adapting to clients' needs.
• Ability to work both independently and in a team environment.
• Resourceful and innovative approach to problem solving.
• Highly motivated and able to grasp complex technologies, tools and concepts and learn quickly.
• Ability to work within tight deadlines, under pressure, and in an entrepreneurial environment.
• Ability to work in strict compliance with all procedures, rules, and regulations.
• Maintain strict confidentiality of sensitive data, records, files, conversations, etc.

IMAGING ENDPOINTS' TEAM CHARACTERISTICS

• Passion to Connect Imaging to the CureTM and pursue a meaningful career by improving the lives of cancer patients through imaging
• Strong desire to be part of a dynamic, global team working closely together and growing year after year in a rewarding environment to help humanity through imaging
• Commitment and caring for our fellow team members, their families, and the communities IE serves - see Caring Endpoints
• Integrity and high ethical standards; we always do the right thing
• High intellect and ingenuity; we enjoy solving problems, finding a better way, and the challenge of making a difference by improving lives
• Structured, organized, detail-oriented, and self-motivated; we approach each day with a detailed plan and excitement to accomplish the day's objectives while striving to improve ourselves and IE everyday
• Accountable; we do what we say and communicative effectively to meet deadlines; we enjoy advancing clinical trials, helping patients, and celebrating success
• High standard for excellence; we proof our own work, hold high standards for ourselves and our team, and always prioritize quality above all else

PHYSICAL REQUIREMENTS

While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms and talk and hear. The employee is frequently required to sit. Specific vision abilities required by this job include close vision, color vision, ability to adjust focus.

Travel: 5 - 10% travel (domestic and international)