Principal, Medical Writer

We need to output HTML fragment with sections: About the role? Actually we have "Who We Are" then "SUMMARY DESCRIPTION:" then "RESPONSIBILITIES:" then "EXPERIENCE:" then "EDUCATION:" then "WORKSTYLE:" then EEO etc. We must not repeat job title as heading. Use

for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. But we need to map content to appropriate headings. The posting includes: Who We Are (company overview) maybe "About the role"? Actually "Who We Are" is company description, not role. Could be "About the role" but we have summary description. We could use "About the role" heading for summary description? The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should create sections only when posting has real specific content. We have content for: Summary description (could be About the role). Responsibilities (clear). Experience (could be Requirements/Qualifications). Education (Qualifications). Workstyle (maybe Schedule? Actually workstyle about remote/hybrid). Could be Schedule? Not exactly. Could be Benefits? Not present. Pay? Not present. So we should include sections: About the role (summary description), Responsibilities, Requirements (maybe combine Experience and Education?), Qualifications (maybe separate). But we must not create thin sections. Let's think: The posting has distinct sections: Who We Are (company overview) - maybe not needed as role-specific; but could be considered "About the role"? Actually "About the role" is about the position, not company. The posting includes "SUMMARY DESCRIPTION:" which describes the role purpose. That fits "About the role". Then "RESPONSIBILITIES:" fits Responsibilities. Then "EXPERIENCE:" fits Requirements/Qualifications. Then "EDUCATION:" could be Qualifications. Then "WORKSTYLE:" could be Schedule (remote/hybrid). There's no Benefits or Pay. So we will output sections: About the role, Responsibilities, Requirements, Qualifications, Schedule. Ensure we only include sections with real content. We need to use

for each heading. Then content: For About the role, we put the summary description paragraph(s). For Responsibilities, we need

• for each bullet. The responsibilities list is a paragraph with sentences separated by line breaks? We'll split each sentence into li. Must preserve all substantive info. We'll extract each duty. Let's list responsibilities from text: - Oversight responsibilities for Medical Writing staff - Works with the Head of Medical Writing to establish and maintain timelines for program planning. - Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports - Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (e.g. PBRERs, DSURs) - Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/Module 5 clinical or integrated summaries). - Manages study team participation in the preparation of such documents, including scheduling and chairing meetings, developing and managing timelines, and managing the document review and comment adjudication processes - Represents CMW at cross-functional team meetings (e.g. study team, development team, other sub-teams). - Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials - Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. - Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments - Works effectively with cross-functional groups within BioMarin - Other tasks as assigned. We'll make each as
• . Experience section: It's a long block with many sub-bullets. We'll need to parse into list items. Could group under Requirements. We'll output
  • each distinct requirement sentence. However many are long sentences with semicolons. We'll split by periods? Better to keep each bullet as a separate line as they appear in original after "EXPERIENCE:" The text after EXPERIENCE: includes paragraphs with headings like Clinical Studies, Management Experience, Medical Writing, Regulatory, Project Management, Program Management, Communication. We could treat each heading as a subheading? But instruction only allows

    for section headings; we could embed

    ? Not allowed. Better to just make a list of items, preserving the content. Could keep paragraphs as

    for each subsection? The rule: Use

    • for any list of duties/requirements/benefits, and

      for prose. So for experience, which is a list of requirements, we should use

      • . We'll break each distinct requirement into its own
      • . Might be many but okay. Let's extract each requirement sentence/experience bullet: From text after EXPERIENCE:: Clinical Studies Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets. Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection. Advanced applied knowledge of: Documentation required for the conduct of clinical studies Protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs) Study results reporting Integrated results reporting Management Experience: Prior administrative and/or functional management experience as a manager of a medical writer team or department in a clinical development setting preferred but not required Demonstrated leadership abilities. Demonstrated ability to plan timelines and resources for multiple documentation projects with shifting priorities. Experience with delegating and overseeing projects and tasks. Medical Writing Writing high-quality documents that support corporate goals and objectives. Experience writing, reviewing, or editing protocols, clinical study reports, INDs, BLA/NDAs, periodic safety documents, and regulatory briefing books required. Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content. Ability to interpret and create complex tabular and graphical clinical data presentations. Ability to interpret basic clinical laboratory tests. Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Regulatory Ability to plan and manage development of the following documents in context of regulatory requirements and guidances, development program plans, and organizational business needs: Standalone’ regulatory documents (eg, protocols, investigator brochures, clinical study reports, IND annual reports) Prior familiarity with standard eCTD IND/NDA work, including: Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) Support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US and EMEA submissions and to provide recommendations for changes in documentation in response to new or modified regulations and guidances. Project Management Ability to plan, resource, and assign multiple simultaneous document development projects (standalone and complex dossiers) with shifting priorities. Ability to keep CMW line management apprised of program document status, to anticipate potential issues within a program, and to raise those issues to CMW line management with proposed mitigations/solutions Ability to support staff in renegotiating timelines during development as necessary. Program Management Capable of managing and maintaining multiple timelines governing multiple projects within a program. Capable of performing resource assessments (short- and long-term) based on projected project needs within a program. Capable of anticipating potential issues within a program and raising those issues to CMW line management with proposed mitigations/solutions. Communication Capable of well organized, concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills. We'll turn each line after a colon or bullet into
      • . Might be many but okay. Education section: "Masters (MS) or higher degree preferred; scientific focus desirable. Evidence of medical writing career development desirable, e.g. European/American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association." We'll make

        maybe? It's not a list but could be

        . However instruction: Use

        • for any list of duties/requirements/benefits, and

          for prose. Education is not a list but could be prose. We'll use

          . Workstyle: "Role may be conducted remotely unless you live within 100 miles of our Headquarters in San Rafael, California or 2nd site in Novato, California. If you do then role reverts to hybrid requiring an onsite presence 2x weekly. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned." We'll make

          for that. Could be considered Schedule? But we can treat as Schedule section? The instruction says use

          for section headings like Schedule. We have content about remote/hybrid, which is schedule/workstyle. We'll make heading Schedule and put that paragraph. Now we need to omit boilerplate: EEO etc. Remove. Now produce HTML fragment:

          About the role

          SUMMARY DESCRIPTION:This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Clinical Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. The Principal Clinical Medical Writer has functional oversight responsibilities for medical writing staff and for the medical writing requirements for clinical development programs, including authoring/editing documents.

          But we need to preserve all substantive info; we should not include the label "SUMMARY DESCRIPTION:" maybe keep as part of paragraph. It's okay. Now Responsibilities:

          Responsibilities

          • Oversight responsibilities for Medical Writing staff
          • Works with the Head of Medical Writing to establish and maintain timelines for program planning.
          • Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
          • Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (e.g. PBRERs, DSURs)
          • Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/Module 5 clinical or integrated summaries).
          • Manages study team participation in the preparation of such documents, including scheduling and chairing meetings, developing and managing timelines, and managing the document review and comment adjudication processes
          • Represents CMW at cross-functional team meetings (e.g. study team, development team, other sub-teams).
          • Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
          • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
          • Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes