Veristat

Medical writer

• The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development.
• Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards.
• Works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.

Principal Medical Writer

Human Resources

• Responsible for providing general Human Resources support, guidance, and subject matter expertise to the Company
• Primarily around matters of employment events such as hires, changes, and departures
• Ensure that employees and managers have appropriate support and resources from the department and external partners

Human Resources Operations Manager

• Independently plans and prepares a range of regulatory documents and/or medical communications to support all phases of product development.
• Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with industry guidelines.

Principal Medical Writer – MedPubs Focus

• The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development.
• Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonization (ICH) and other regulatory guidelines, and individual company document standards.
• Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents.
• Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents).
• Author documents per client specifications, templates, style guides, and other guidance documents.
• Author documents per regulatory authority guidelines and requirements.
• Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result.
• Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work.
• Manage budget for a low complexity project, including all contributors (writers, editors).
• Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus.
• Maintain collaborative, proactive, and effective communication with both clients and internal teams.
• Lead project-related meetings and teleconferences.
• Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements.

Principal Medical Writer – Nonclinical Focus

Business Development Rep

• Responsible for the development and expansion of new business opportunities within established accounts and prospective clients.
• Provides leadership for overall business planning.
• Identifies and develops sales leads, managing the sales process through contract closure.
• Prepares and conducts project-specific client presentations.
• Liaises between the client and Company on all sales activities and requirements.
• Assists with the development of promotional material for Company recognition.
• Works closely with Project Management and Finance to establish strategic partnerships with clients.

Senior Business Development Director

• Responsible for driving growth of Veristat’s Regulatory Science and Medical Writing services across pharmaceutical, biotechnology, and life sciences clients.
• Focuses on developing new business opportunities and expanding existing accounts by positioning high-value solutions including regulatory strategy, submission support, regulatory operations, and scientific/medical writing.
• Lead strategic sales efforts, identify client needs across the product development lifecycle, and partner cross-functionally to deliver tailored solutions that support regulatory approvals and clinical development success.
• Serve as the primary liaison between the client and Veristat for all sales-related activities, enhancing the Company’s visibility, credibility, and market presence within regulatory and scientific services.
• Collaborate closely with Regulatory, Medical Writing, Clinical, Project Management, and Finance teams to ensure alignment of client needs with service delivery and to drive long-term strategic partnerships.

Senior Business Development Director – Regulatory, Medical Writing

• The Account Development Specialist (ADS) II supports Veristat’s ABM strategy and plays an essential role in achieving Veristat’s growth and revenue targets.
• Your primary goal is to develop new accounts and assist with growth in existing target accounts, generating qualified meetings, and driving new business opportunities to RFP, all while ensuring defined KPI's are achieved.
• S/he conducts personalized outreach via phone and electronic media, after researching accounts, prospects, and products to craft customized content that communicates the value of Veristat solutions and brand.
• Documenting activities, and following standard processes is required.
• The ADS II will also assist with capabilities meetings, campaign outreach or follow-up, progressing qualified leads and a variety of internal business initiatives, process improvements, and trainings.
• S/he works with direction and in collaboration with Business Development, Marketing, and Account Development.