Associate Director, Medical & Regulatory Writing

We need to output HTML fragment with sections: About the role? Actually the posting includes intro paragraphs. We need to use

for section headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title as heading. No Job ID etc. Remove boilerplate like EEO, etc. Also remove application instructions. We need to parse the posting: It starts with marketing text about Kura Oncology, then "Essential Job Functions" which is responsibilities. Then "Job Specifications" which includes qualifications, requirements, skills. Then "The base range for an Associate Director is $184,000 - $211,000." That's Pay. Then "Kura's compensation package also includes generous benefits, equity, and participation in an annual target bonus." Then list of benefits: Kura’s Values... then "The Kura Package Career advancement/ development opportunities Competitive comp package Bonus 401K + Employer contributions Generous stock options ESPP Plan 20 days of PTO to start 18 Holidays (Including Summer & Winter Break) Generous Benefits Package with a variety of plans available with a substantial employer match Paid Paternity/Maternity Leave In-Office Catered lunches Home Office Setup Lifestyle Spending Stipend Commuter Stipend (Boston Office) Regular employee social activities, including happy hours, monthly birthday celebrations, Kura Koffee Talks, and much more!" That's Benefits. Schedule? Not mentioned. So we should not include Schedule section. We need sections: About the role (intro), Responsibilities (Essential Job Functions), Requirements (maybe Job Specifications includes qualifications, experience), Qualifications (maybe education), Skills (maybe abilities), Benefits, Pay. We need to decide how to split. The instruction: Use headings for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can include those that have content. We need to preserve all substantive information, not invent or summarize away detail. So we need to include details from the posting under each section. We must not repeat job title as heading. The job title is Associate Director, Medical & Regulatory Writing. Not to be used as heading. We need to output only HTML fragment, no /, no markdown fences. Let's craft:

About the role

... intro paragraphs ...

Then

Responsibilities

• ... each essential function ...

We need to preserve all details; we can break into bullet points for each sentence or clause. Must not lose info. We need to be careful not to include boilerplate like "Performs other duties as assigned" maybe keep? It's part of responsibilities. It's okay. We need to exclude duplicated lines: there are duplicate lines like "Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs." appears twice. We should keep only once? The instruction: remove duplicated lines. So we should deduplicate. Also duplicate "Support the development, improvement and maintenance of medical writing work practice documents, SOPs, and document templates to ensure consistency and efficiency." appears twice. Keep once. We need to preserve all substantive information; deduplication is allowed. Now Job Specifications: includes education, experience, skills, etc. We'll split into Requirements, Qualifications, Skills perhaps. But we need to avoid thin sections. Could combine Requirements and Qualifications? But headings are separate; we can include both if they have content. Let's extract: Education: Masters or advanced degree in scientific, medical, or clinical discipline (eg, PhD, PharmD, or equivalent) is required. PhD degree is preferred. Experience: Must have a minimum of 8-10 years of relevant industry experience as a regulatory/scientific writer in a pharmaceutical, biotech, or CRO environment. Must have CTD experience, vendor oversight a plus. Oncology experience preferred. Experience authoring clinical study reports, protocols, protocol amendments, Investigator’s Brochures. Experience authoring briefing books and Module 2 clinical summaries (2.5, 2.7.3, 2.7.4) is a plus. Ability to work effectively in a collaborative team environment where results are achieved through influence, cooperation, and the incorporation of multiple points of view. Solid understanding of drug development, clinical research, data analysis, Common Technical Document (CTD), ICH guidelines, GxP, regulatory interactions, and relevant regulations, requirements and guidance associated with document preparation and submission. Ability to manage competing priorities in a fast-paced environment. Excellent problem solving, organizational, and analytical critical thinking skills. Excellent written and verbal communication skills. Strong attention to detail related to consistency, grammar, syntax, and formatting. Familiarity with eCTD-compliant templates and with the use of document formatting tools such as ISI writer, Liquent Smart Desk, Acumen Stylus, or other formatting tools is a plus. Proficient in MS Office Suite, EndNote, and Adobe Acrobat. Experience with use of an EDMS such as Documentum, Core Dossier, or Veeva. Ability to travel up to approximately 10% of the time. Makes decisions for assigned programs or functional areas, balancing priorities and resolving routine challenges; escalates high-impact or cross-functional decisions as needed. Facilitates cross-functional coordination for assigned programs or initiatives, ensuring alignment and timely execution of deliverables. Proficiency in the use of Veeva or equivalent It software for document creation, review, and QC including applications for citation of literature references and creation of list of references in Word documents. (This appears earlier in responsibilities but also in specs; we can keep under Skills.) Maintain current knowledge of industry trends and best practices for medical writing. Now we need to map to sections: Requirements: maybe the mandatory requirements: education, years experience, CTD experience, etc. Qualifications: maybe preferred qualifications: PhD, oncology experience, briefing books, etc. Skills: abilities like problem solving, communication, etc. But we need to avoid thin sections; we can combine some. Let's decide: - About the role: intro paragraph(s). - Responsibilities: all Essential Job Functions bullet list. - Requirements: mandatory: Masters or advanced degree required; 8-10 years experience; CTD experience; ability to author clinical study reports, protocols, etc.; proficiency in Veeva or equivalent; ability to travel up to 10%; etc. - Qualifications: preferred: PhD preferred; oncology experience preferred; experience authoring briefing books and Module 2 clinical summaries; familiarity with eCTD templates and formatting tools; experience with EDMS; etc. - Skills: problem solving, organizational, analytical thinking, written/verbal communication, attention to detail, ability to manage priorities, collaborative team work, decision making, cross-functional coordination, maintaining knowledge of industry trends. - Benefits: list from Kura Package. - Pay: base range $184,000 - $211,000; note individual pay may vary; compensation package includes generous benefits, equity, annual target bonus. We should not include Schedule. Now we need to ensure we don't include boilerplate like EEO, privacy notice, etc. Remove those lines. Also remove duplicated lines. Now craft HTML. We'll need to escape any special characters? Not needed. Let's write. First, About the role: combine the introductory paragraphs before "Essential Job Functions". The text: "Are you ready to join a team committed to making a meaningful impact on cancer treatment through the discovery and development of precision medicines? At Kura Oncology, you have an opportunity to be a part of something bigger, with a lasting impact that you can be proud of. At Kura Oncology, we are working to change the paradigm and improve the science of cancer treatment. As an organization, we strive to cultivate a diverse and talented professional culture driven to develop precision medicine therapeutics. As we continue to build a leading biotech organization with a strong culture, a patient-focused mindset and a team focused on relentless execution, we are looking for innovative, passionate professionals to join us and make our vision a reality. To succeed at Kura, you will need to have a demonstrated ability for excellence in drug discovery and development and a roll-up your sleeves attitude. The ideal candidate will possess a values-driven work style where integrity and grit drive all behaviors, decisions, and actions." We'll put that in

. Now Responsibilities: list each essential function. Let's extract bullet points from the long paragraph after "Essential Job Functions". We'll need to split into sensible bullet items. Original text after "Essential Job Functions": "The Associate Director, Medical & Regulatory Writing serves as a subject matter expert in the writing and production of clinical documents such as the writing of clinical protocols, protocol amendments, clinical study reports, Investigator’s Brochures, and briefing books. This role is also accountable for Clinical Trial Transparency & Disclosure (CTD) responsibilities and oversight of vendors carrying out such work. The position requires the ability to work collaboratively with cross-functional teams in a fast-paced environment. The qualified candidate will also have experience in oversight of external vendors. There needs to be a very strong understanding of document timelines as planning is critical. Serves as the assigned medical writer and subject matter expert in preparing clinical regulatory documents through all phases of clinical research.Execute clinical trials transparency and disclosures (CTD) book of work and provide vendor oversightCollaborates with the cross-functional team comprised of regulatory affairs, clinical development, clinical operations, biostatistics, pharmacology, translational research, manufacturing, etc. to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.Works closely with the study team to reach consensus on timelines for deliverables.Completes documents according to agreed-upon timelines for deliverables and follows up with the study team as needed to meet timeline commitments.Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.Support the development, improvement and maintenance of regulatory and scientific writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.Represent medical writing in cross-functional team meetings.Collaborate with department heads and staff members of cross-functional groups, including clinical development, clinical operations, data management, biostatistics, regulatory affairs, and medical affairs as necessary to deliver documents with high quality on time.Adhere to established regulatory standards, including ICH-E3 guidelines and company SOPs.Support the development, improvement and maintenance of medical writing work practice documents, SOPs, and document templates to ensure consistency and efficiency.Lead the development of overall global clinical trials transparency and disclosures policy with key stakeholders, updating the policy as necessaryLead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, websites, databases, and documentsEnsure lean writing practices for regulatory documents such as Clinical Trial Protocols, Investigator's Brochures, Informed Consent templates and Clinical Study Reports to minimize CCI and PPDAnalyze, validate, and prioritize complex and dynamic information from a diverse range of sources in response to technical and operational challengesManage, track and present assigned book-of-work, compile and report performance metricsManage the preparation of plain language (layperson) synopses and summaries and redaction of clinical documents in accordance with FDA requirements, EMA Policy 0070, EU Clinical Trial Regulation, Health Canada Public Release of Clinical Information (PRCI), and other global regulationsEducate and provide company-wide awareness of transparency/disclosure regulations and industry trends, as well as requirements for layperson summaries and clinical study diversity planning.Coordinate efforts of cross-functional teams to produce documents & postings (e.g., plain language (layperson) summaries, interim and/or results postings, and redaction documents), acting as liaison between the vendor and internal teamsFor relevant trials, collaborate with internal and external stakeholders to develop and implement diversity action plans in accordance with FDA guidanceWork on multiple projects/across programs, coordinating work plans that align with corporate timelines and strategic plansOvers