Title: Director/Senior Director, Medical Writing Department: Regulatory Affairs Reports To: VP, Regulatory Affairs Status: FTE About vTv vTv Therapeutics is a clinical stage biopharmaceutical company focused on developing oral, small molecule drug candidates. vTv has a pipeline of clinical drug candidates led by cadisegliatin, a potential adjunctive therapy to insulin for the treatment of type 1 diabetes. vTv and its development partners are pursuing additional indications, including type 2 diabetes and other chronic conditions. Description vTv is seeking a Director/Senior Director, Medical Writing to lead the strategy, development, and delivery of high-quality clinical and regulatory documents supporting our global clinical development programs - including clinical study protocols, investigator brochures, clinical study reports (CSRs), briefing documents, INDs, NDAs/BLAs, MAAs, safety reports, and scientific publications. This role partners closely with Regulatory Affairs, Clinical Development, Biostatistics, Clinical Operations, and other functional teams to ensure the timely preparation of scientifically rigorous and regulatory-compliant documents across the product lifecycle. The Director/Senior Director serves as the medical writing lead for major development programs, ensuring alignment of messaging and scientific integrity across regulatory submissions, clinical documentation, and external communications. This is a unique opportunity to contribute to the development of a potential first-in-class therapy in diabetes, working in a collaborative and science-driven environment. This position is fully remote. Key Responsibilities - Medical Writing - - Provide strategic leadership and oversight of the Medical Writing function, ensuring the delivery of high-quality clinical and regulatory documentation. - Establish document standards, templates, style guides, and best practices aligned with regulatory expectations (ICH, FDA, EMA). - Oversee document planning, timelines, and resource allocation across programs to ensure on-time delivery of key regulatory and clinical deliverables. - Lead identification and management of external medical writing vendors and consultants as needed. - Maintain awareness of evolving regulatory guidance and industry best practices relevant to clinical and regulatory documentation - Supervise (directly or indirectly) a team of medical writers and external writing vendors, and may recruit, manage, mentor, and develop writing staff. - Clinical and Regulatory - Serve as the medical writing lead for assigned development programs, partnering with clinical, regulatory, and statistical leaders providing strategic guidance and development to ensure clear and consistent scientific communications. - Lead the preparation and review of major clinical documents as applicable, including: - Clinical study protocols and protocol amendments - Clinical study reports (CSRs) - Investigator brochures (IBs) - Safety narratives - Scientific manuscripts and conference abstracts - Ensure scientific accuracy, clarity, and consistency across clinical documents. - Collaborate with cross-functional teams to present complex clinical and scientific data into clear, regulatory-compliant documents. - Manage clinical development processes and document archival requirements - Provide strategic input into regulatory submissions, ensuring consistency of messaging across documents and alignment with regulatory strategy. - Support preparation of documents for regulatory meetings with agencies (e.g., FDA Type B meetings, End-of-Phase meetings, advisory committees) and major regulatory documents, including IND, CTA, NDA/BLA, and MAA submission components (e.g., ISS/ISE summaries, Module 2 documents, Clinical overviews, etc.) - Leadership - - Serve as the strategic medical writing representative on program teams and development governance committees. - Provide expert guidance on document strategy, messaging, and expectations. - Contribute to corporate initiatives related to scientific communication, publication strategy, and document quality standards. - Mentor internal staff and foster a culture of scientific rigor, clarity, and excellence in medical writing. - Represent vTv on high impact/priority task forces across vTv or external to the company. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: - Advanced degree preferred (MS, PhD, PharmD, MD, or equivalent scientific discipline preferred). - 12–15+ years of medical writing experience within the pharmaceutical or biotechnology industry, CRO, or related environment. - Extensive experience preparing clinical and regulatory documents supporting INDs and NDAs/BLAs. - Demonstrated leadership of complex cross-functional writing projects and submission programs. - Experience managing medical writing teams and external vendors preferred. Skills - Exceptional scientific writing and editing ability. - Strong strategic thinking and problem-solving skills. - Ability to translate complex scientific data into clear, concise, and regulatory-compliant documentation. - Strong cross-functional leadership and collaboration skills. - Excellent communication and interpersonal skills with the ability to influence multidisciplinary teams. Knowledge - Expert knowledge of ICH guidelines and global regulatory submission standards. - Familiarity with FDA and EMA expectations for clinical documentation and regulatory submissions. - Experience with word templates, electronic submission formats (eCTD) and document management systems. LICENSES/CERTIFICATIONS: - None required - AMWA certification preferred but not required. TRAVEL REQUIREMENTS: - Ability to travel occasionally for internal meetings, regulatory interactions, or scientific conferences. - Requires approximately 5 - 10% travel. - This is remote position

Role Description We are sharing a specialised part-time consulting opportunity for highly accomplished creative writers with deep expertise in literary craft, editorial judgment, and high-quality narrative writing across multiple formats. This role supports an exciting collaboration with leading frontier AI research laboratories focused on improving how advanced AI systems generate nuanced, high-quality narrative content. Selected professionals will review and refine AI-generated content across plays, novels, and short stories, helping improve literary quality, structure, tone, coherence, originality, and thematic depth. This opportunity is especially well-suited to experienced playwrights, novelists, and short story authors with significant published work, recognised literary achievement, and strong editorial instincts shaped by years of professional writing practice. Key Responsibilities - Creative Writing Review & Refinement - Review and refine AI-generated content across plays, novels, and short stories. - Apply strong literary judgment to improve narrative quality, stylistic precision, and structural coherence. - Help ensure that outputs reflect high standards of storytelling and craft across multiple literary formats. - Literary Evaluation & Editorial Feedback - Evaluate outputs for literary quality, structure, tone, and thematic depth. - Provide detailed editorial feedback to improve coherence, originality, and overall narrative effectiveness. - Support AI training workflows through nuanced critique informed by real-world writing and publishing experience. - Narrative Craft & Quality Calibration - Apply expertise in structure, voice, dialogue, and character development across formats. - Help improve how advanced AI systems handle creative storytelling, stylistic control, and narrative judgment. - Contribute domain-informed literary standards to high-impact AI training and evaluation workflows. Qualifications - 10+ years of experience in creative writing, including playwriting, novel writing, and/or short fiction. - A substantial body of published work such as novels, staged plays, or multiple short stories in recognised outlets. - Work featured in prestigious literary publications, journals, anthologies, or professional productions. - Recognised literary awards, fellowships, or honors across any of the three disciplines. - Exceptional command of narrative craft, including structure, voice, dialogue, and character development. - Strong ability to critique and refine written work with attention to style, coherence, and thematic depth. Preferred Qualifications - Experience working across more than one literary form such as fiction, drama, or short-form narrative. - Strong editorial experience involving revision, critique, or literary development. - Ability to evaluate nuanced stylistic and thematic qualities in narrative writing. - Comfort applying literary judgment to structured review and refinement tasks within AI-focused workflows. Benefits - Contribute specialised creative writing expertise to a cutting-edge AI collaboration. - Help improve how advanced AI systems generate nuanced, high-quality narrative content. - Work on high-impact literary evaluation and refinement tasks with strong creative relevance. - Flexible remote work with structured expectations and competitive hourly compensation. Contract Details - Independent contractor role. - Fully remote with flexible scheduling. - Hourly compensation of $75–$150 per hour. - Project-based opportunity with flexible participation. - Projects may be extended, shortened, or concluded early depending on project needs and performance. - Weekly payments via Stripe or Wise. - Work will not involve access to confidential or proprietary information from any employer, client, or institution. - Please note: We are unable to support H1-B or STEM OPT candidates at this time. - Start date: Immediate. About the Platform This opportunity is available through a leading AI-driven work platform that connects domain experts with frontier AI research projects. Experts contribute to improving advanced AI systems by providing specialised expertise across real-world workflows, structured evaluation, model training support, and domain-specific content validation.

• Help evolve and execute Walker Sands’ approach to executive and brand thought leadership across accounts • Position clients as credible, differentiated voices in their industries • Partner with PR, strategy and account teams to align thought leadership with media, speaking and brand opportunities • Identify timely topics and narratives that connect client expertise to industry trends and conversations • Write and edit a range of content, including thought leadership (bylines, LinkedIn posts, keynote materials, expert commentary) as well as blogs, ebooks, data reports, white papers, campaign assets and other marketing content • Contribute to integrated content programs that support brand awareness, engagement and demand generation goals • Collaborate directly with executives and subject matter experts to capture their voice and perspective, as well as with internal teams to develop content aligned to campaign objectives • Translate complex or technical ideas into clear, engaging and authoritative content • Ensure all content meets a high bar for quality, clarity and originality • Serve as an internal expert on executive and brand thought leadership best practices • Guide teams on tone, messaging and content formats that resonate with media and target audiences • Contribute to the development of frameworks, examples and training that elevate thought leadership across the agency • Identify opportunities to expand thought leadership programs for existing clients and connect them to broader content and campaign initiatives • Present ideas and content to clients with confidence and clarity • Provide editorial direction and feedback to other writers and team members • Contribute to new business efforts through ideation and strategic input • Flex across content types and priorities, stepping in to support high-priority or complex assignments beyond thought leadership • Collaborate cross-functionally to ensure content aligns with broader campaign, communications and marketing goals

• Draft 90-100+ comprehensive and persuasive settlement demand letters for personal injury cases/month. • Review and summarize medical records, bills, and supporting documentation utilizing AI software. • Analyze liability and clearly outline arguments for insurance carriers. • Calculate and present special and general damages. • Ensure accuracy, completeness, and organization of demand packages. • Collaborate with attorneys, case managers, and support staff. • Maintain productivity in a high-volume environment.