Associate Director, Medical Writing

We need to output HTML fragment with sections: About the role? The posting includes description of company and role. We need headings:

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We should only include sections that have real content. We need to parse the posting. Content: - Company description: "Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com." - Position details: "We are seeking a highly motivated medical writer to join our medical writing team as an Associate Director or Senior Manager. Reporting into the Head of Medical Writing, the Associate Director/Senior Manager of Medical Writing (Clinical and Regulatory) serves as a scientific and strategic lead responsible for researching, authoring, editing, and managing high-quality clinical and regulatory documents in support of Encoded's programs. Working in partnership with colleagues across Clinical Development, Regulatory Affairs, Quality, Biometrics, Medical Affairs, Commercial, CMC, Nonclinical Development, and executive leadership, this individual will help interpret data, formulate key messaging, and drive the development of regulatory and clinical documents. These documents include clinical study protocols and clinical protocol amendments, Investigator Brochures, responses to regulatory authority questions, clinical study reports, patient narratives, clinical development plans, IND submissions, integrated summary reports, and components of Modules 1 and 2 of BLA/MAA submissions. The role will also support the continued development of medical writing infrastructure and processes, including best practices and resources for document management and timelines, template and shell creation, lexicon and document QC, publishing, and editing standards." That's about the role. Then "Responsibilities" list: bullet points. Then "Requirements" list: bullet points. Then "Benefits" list: bullet points. Then "Pay": salary ranges. Also "Schedule"? Not mentioned. So we should not include Schedule. Also "Qualifications" maybe same as Requirements? The instruction says use headings like Qualifications, Skills, Benefits, Pay, Schedule. We have Requirements; we could map to Requirements heading. Also maybe Skills separate? The posting includes "Exceptional computer skills and familiarity with key software..." which could be under Skills. But we can include Skills as a subsection under Requirements? The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have sections: About the role, Responsibilities, Requirements, Skills, Benefits, Pay. We need to decide where to put each piece. The Requirements block includes many items: advanced degree, experience, etc. Also includes "Exceptional computer skills and familiarity with key software..." That could be considered Skills. We could split: Requirements (education/experience) and Skills (technical). But we must not invent sections if content is thin. Let's see if we have enough for Skills: "Exceptional computer skills and familiarity with key software and cloud-based programs for document creation (e.g., Microsoft Office, Adobe, etc.) and sharing/editing (e.g., SharePoint, GraphPad, etc.)". That's a specific skill. Could be a Skills section. Also there is "Ability to work, communicate, and collaborate..." which is more soft skills; could be under Skills as well. But we could also keep everything under Requirements and not create Skills if it's thin. However we have enough for Skills maybe. Qualifications: The posting includes "Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred with a minimum of 5+ years of biopharmaceutical or scientific, medical or regulatory experience, or a Master's degree with 8+ years, or a Bachelor's degree in molecular biology, genetics, or a related scientific discipline with 12+ years of relevant experience". That's qualifications. Could be under Qualifications heading. But we already have Requirements. The instruction says we can use either Requirements or Qualifications; we need to decide which to use. Since the posting uses "Requirements" heading in the text, we should follow that and use

Requirements

. Then we could also have Skills separate if we want. But we must not repeat headings with filler. Let's decide to have sections: About the role, Responsibilities, Requirements, Skills, Benefits, Pay. Now we need to extract content for each. About the role: combine company description and position details paragraph(s) before Responsibilities. That includes the first two paragraphs (company description and position details). We'll put that in

elements. Responsibilities: list of bullet points after "Responsibilities". We need to capture each bullet as

. The bullet points start after "Responsibilities" line: "Own and manage assigned clinical, regulatory, and preclinical deliverables..." etc. We'll need to extract each bullet. Let's copy the responsibilities text: "Own and manage assigned clinical, regulatory, and preclinical deliverables in support of Encoded's programs. Documents may include clinical study protocols; Investigator Brochures; clinical study reports; components of Modules 1, 2, and 5 of BLAs; INDs/CTDs and amendments; analysis and development plans; safety updates and annual reports; narratives and summaries; briefing books; and other key program documents Partner with cross-functional teams to analyze and interpret clinical data, including internal and external data sources, and translate findings into clear, scientifically accurate content, conclusions, and key messaging; perform literature and scientific database searches as needed to support analyses and background summaries Contribute medical writing expertise on cross-functional teams, helping shape document strategy, organization, and messaging while supporting consistency, efficiency, and clarity across assigned deliverables Support the development and implementation of scalable medical and scientific writing infrastructure, including templates, shells, processes, standards, style guides, workflows, operating procedures, document QC practices, publishing readiness, and editing standards Develop realistic timelines for assigned deliverables in collaboration with cross-functional teams, manage multiple writing projects in parallel, communicate risks or resource needs, and coordinate workload with the Head of Medical Writing to meet program goals Collaborate with internal and external authors, vendors, service providers, and clinical investigators to support document development, align on expectations, and track milestones and deliverables Coordinate review cycles and incorporate or adjudicate comments from internal and external stakeholders, producing final deliverables that are high quality, scientifically accurate, compliant, and aligned to agreed key messages Ensure document content, format, and style adhere to applicable company standards, style guides, and regulatory requirements, including ICH, FDA, EMA, and other appropriate guidelines Review Statistical Analysis Plans and Tables, Figures, and Listings to support appropriate data presentation for clinical study reports and other regulatory documents; provide feedback to project teams as needed" That's 9 bullet points. Now Requirements: after "Requirements" heading. Let's extract: "Advanced scientific degree (PhD, PharmD, MD, or equivalent) preferred with a minimum of 5+ years of biopharmaceutical or scientific, medical or regulatory experience, or a Master's degree with 8+ years, or a Bachelor's degree in molecular biology, genetics, or a related scientific discipline with 12+ years of relevant experience Prior work experience at a biotech or pharmaceutical company is preferred; experience in a smaller company or rare disease environment is ideal Writers with multiple contributions to BLA/NDA submissions are preferred A strong background and track record of producing high-quality scientific and medical documents for internal and external distribution is required Ability to work, communicate, and collaborate with colleagues and external stakeholders as a team player with transparency in a data-driven, fast-paced, and exciting environment Capability and comfort with prioritizing multiple projects, deliverables, and timelines, exercising thoughtful judgment, and applying strong problem-solving and decision-making skills. Ability to think ahead and identify opportunities for change and improvement, with an emphasis on operations and efficiency Exceptional computer skills and familiarity with key software and cloud-based programs for document creation (e.g., Microsoft Office, Adobe, etc.) and sharing/editing (e.g., SharePoint, GraphPad, etc.)" That's 7 bullet points. Now Skills: we could separate the computer skills bullet as Skills. But we already included that in Requirements. If we create Skills section, we need to move that bullet out of Requirements. Let's decide to keep Requirements as the list above excluding the computer skills bullet, and then Skills section containing that bullet (and maybe also the ability to work, communicate, collaborate? but that's more soft skill). However the instruction says prefer a few substantive sections over many thin ones. If we split, we might have thin Skills section with just one bullet. Might be better to keep everything under Requirements and not create Skills. But we have to follow the instruction: "Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule)." It's just examples; we are not required to use all. So we can omit Skills if we don't have enough distinct content. The computer skills bullet is part of Requirements; we can keep it there. Thus sections: About the role, Responsibilities, Requirements, Benefits, Pay. Now Benefits: after "Benefits" heading. Let's extract: "Comprehensive benefits package, including competitive employer premium contributions Meaningful stock option grants PTO, sick time and holiday pay Generous Parental Leave program Pre-tax medical and dependent care programs STD, LTD, Life and AD&D Professional development opportunities Team-building events Fully stocked micro - kitchen Fitness center at South San Francisco location" That's 10 bullet points. Now Pay: after "For candidates based in the SFBA area, the salary range for this position is 180,000 - 210,000" and "For candidates based outside the SFBA area, the salary range is 160,000 - 190,000". Also there is sentence about discretionary bonus, stock incentives, etc. We should include that as part of Pay section? The instruction: include Pay section only if posting actually states them. It does state salary ranges. Also mentions discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. But benefits already covered. We can include Pay section with salary ranges and mention bonus/stock incentives. We need to preserve all substantive information; do not invent or summarize away detail. So we need to include the sentences about discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package. However paid time off is already in Benefits; but we can still mention it in Pay? Might be duplication but we must preserve all info; we can include it in Pay section as well, but that would duplicate. Better to keep Pay section focusing on compensation: salary ranges, discretionary annual bonus, discretionary stock-based long-term incentives. The benefits package is already covered in Benefits section; we can mention that it's also part of compensation but we can avoid duplication by not repeating benefits details. However the sentence "This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives, paid time off, and a benefits package." includes paid time off and benefits package which are already covered elsewhere. To preserve all info, we could include that sentence in Pay section, but then we would be repeating paid time off and benefits package. The instruction says "Preserve ALL substantive information; do NOT invent or summarize away detail." It doesn't forbid duplication, but we should avoid unnecessary duplication? Not explicitly forbidden. However we should aim to not repeat same info unnecessarily. But we could include the sentence as is, and Benefits section already lists benefits; duplication may be okay but could be considered redundant. I'd rather keep Pay section with salary ranges and the bonus/stock incentives, and mention that the position is also eligible for a discretionary annual bonus and discretionary stock-based long-term incentives. The paid time off and benefits package are covered in Benefits; we can omit repeating them to avoid duplication