Director, Medical Writing
Beeline Medicines · United States · 1 mo ago
RemoteRemoteHealthcare$199k–$258k/yrFull-time
We need to output HTML fragment with sections: About the role? Actually the posting includes "About Beeline Medicines" then "Job Summary". The instructions: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones.
We need to decide which sections to include: About the role (maybe Job Summary), Responsibilities (Essential Duties And Responsibilities), Qualifications (Education and experience), Skills (maybe some listed), Benefits (they gave benefits description), Pay (they gave Salary Range). Schedule? Not given. Work Arrangement & Location: Remote - could be considered Schedule? Not exactly schedule. Might be considered "Work Arrangement". Not in list of allowed headings but we could maybe include under "About the role"? The instruction says use headings from list; we can also possibly include other headings if needed? It says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely we should stick to those headings only. So we need to map content.
We have:
- About Beeline Medicines (company overview) could go under "About the role"? Actually "About the role" is about the job, not company. But we could include company overview under "About the role"? Might be okay. However we also have "Job Summary". Could combine.
Better: Use "About the role" for job summary and responsibilities? But we also have separate Responsibilities section. So "About the role" could contain the Job Summary paragraph. Then "Responsibilities" for Essential Duties And Responsibilities. Then "Qualifications" for Education and experience etc. Then "Skills" maybe for specific skills like proficiency with Veeva Vault, AI-assisted tools, publication planning, etc. Then "Benefits" for benefits description. Then "Pay" for salary range. "Schedule" not present, so omit.
We must not include filler like "commensurate with experience". The salary range is specific: $199,000 - $258,000 USD. That's specific, so include Pay section.
Benefits: they gave description but note "Benefits vary by location". That's somewhat vague but still they gave some specifics: Competitive health and wellness coverage, Paid time off, public holidays, additional leave entitlements, Flexible work arrangements / hybrid schedule. That's substantive enough. So include Benefits.
We must remove EEO boilerplate etc.
We need to output only HTML fragment, no /, no markdown fences.
We'll produce something like:
About the role
Job Summary ...
But we need to include the company overview? Might be part of About the role? Could add a paragraph about Beeline Medicines before job summary. The instruction: "Do NOT repeat the job title as a heading (the page already shows it)". It doesn't forbid including company overview. So we can include it in About the role.
Let's extract the Job Summary paragraph: "The Director, Medical Writing is a hands-on leadership role responsible for clear scientific messaging and for the development, coordination, and delivery of high-quality regulatory, nonclinical, clinical, and other scientific documents in support of the company's I&I pipeline. This position combines active document authorship with functional leadership of medical writing, ensuring that deliverables meet high standards of scientific accuracy, regulatory compliance, and clarity. The Director owns the design and implementation of medical writing processes, templates, and standards, builds and manages internal writing capability, and directs the selection, oversight, and performance of external writing vendors within an agreed budget. The role partners closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external vendors to plan, author, review, and deliver documents supporting critical regulatory milestones, including INDs, amendments, briefing packages, and selected NDA/BLA components. This role is expected to remain closely involved in the hands-on execution of core documents while carrying accountability for people management, vendor and budget management, and delivery across multiple concurrent programs as submission activity expands."
We can keep that.
Then About Beeline Medicines paragraph: "Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully."
We could put that before the Job Summary in About the role.
Now Responsibilities: list of duties. We need to convert to - . The responsibilities are a long paragraph with many items separated by periods. We need to extract each duty as list items. Let's parse:
"Own day to day execution of medical writing activities, authoring, coordinating, and reviewing key clinical and regulatory documents, including protocols and amendments, CSRs, IBs, SAPs, ICFs, INDs/CTAs, and selected BLA/NDA components, ensuring scientific accuracy, regulatory compliance, and consistency of content."
"Contribute to defining the strategy for submission narratives and key messages, leading scientific messaging consistency across CTD modules."
"Represent Medical Writing in cross functional and governance forums and drive alignment on submission strategy and document readiness."
"Direct planning and sequencing of document deliverables with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs; own integrated timelines and trackers across concurrent programs, coordinate cross functional review cycles, anticipate and mitigate bottlenecks, and provide regular, transparent status updates to cross functional teams and leadership."
"Manage and develop medical writing staff and contract writers"
"Manage medical writing vendors, including selection, scope definition, deliverable tracking, quality oversight, and performance review."
"Own the Medical Writing budget and forecast internal FTE and vendor capacity against the program plan."
"Establish, document, and maintain the process for authoring, review, QC, and approval of regulatory documents submitted to health authorities, including SOPs, style guides, and templates aligned with ICH and regional requirements."
"Develop and deliver training to the cross functional team to ensure adoption of the agreed process."
"Support Health Authority briefing documents, meeting request packages, and written responses to Agency queries."
"Manage the Medical Writing function budget and resource planning, including FTE capacity and vendor utilization forecasting."
"Perform other duties and responsibilities as assigned."
We can make each bullet.
Now Qualifications: includes Education, experience, etc. We'll need to list as
- . Let's extract:
"Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required."
"Minimum of 10+ years of medical writing experience in the pharmaceutical or biotech industry,"
"Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages."
"Deep scientific expertise in immunology, inflammation, or autoimmune disease is preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas."
"Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment."
"Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards."
"Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment."
"Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault or equivalent."
"Strong publication planning experience, including familiarity with ICMJE authorship guidelines, journal submission processes, and scientific congress submission requirements."
"Proficiency with AI-assisted authoring and review tools applied to regulatory and clinical documents is strongly preferred, including practical understanding best prompt practices, limitations, quality control requirements, and appropriate use in a regulated environment."
"Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable."
"Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning."
"Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities."
"Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners."
"Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams and board-level stakeholders."
We could split into Qualifications and Skills sections. The instruction includes Skills as a possible heading. So we could put some of the skill-based items under Skills: proficiency with Veeva Vault, AI-assisted tools, publication planning, communication skills, presentations, etc. The rest under Qualifications: education, years experience, expertise, ability to manage, knowledge of regulations, experience developing SOPs, experience building/scaling function, leadership ability, influencing, etc.
But we need to avoid thin sections. Perhaps combine Qualifications and Skills into one Qualifications section? But we have both headings allowed. We could make Qualifications for education/experience/knowledge, and Skills for technical proficiencies. That seems reasonable.
Let's decide:
Qualifications (
Qualifications
) containing:
- Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required.
- Minimum of 10+ years of medical writing experience in the pharmaceutical or biotech industry
- Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages.
- Deep scientific expertise in immunology, inflammation, or autoimmune disease is preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas.
- Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment.
- Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards.
- Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment.
- Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable.
- Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning.
- Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities.
Skills (Skills
) containing:
- Proficiency with document management systems, electronic submission tools, and publishing platforms such as V
for prose. Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. We need to decide which sections to include: About the role (maybe Job Summary), Responsibilities (Essential Duties And Responsibilities), Qualifications (Education and experience), Skills (maybe some listed), Benefits (they gave benefits description), Pay (they gave Salary Range). Schedule? Not given. Work Arrangement & Location: Remote - could be considered Schedule? Not exactly schedule. Might be considered "Work Arrangement". Not in list of allowed headings but we could maybe include under "About the role"? The instruction says use headings from list; we can also possibly include other headings if needed? It says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Likely we should stick to those headings only. So we need to map content.
We have:
- About Beeline Medicines (company overview) could go under "About the role"? Actually "About the role" is about the job, not company. But we could include company overview under "About the role"? Might be okay. However we also have "Job Summary". Could combine.
Better: Use "About the role" for job summary and responsibilities? But we also have separate Responsibilities section. So "About the role" could contain the Job Summary paragraph. Then "Responsibilities" for Essential Duties And Responsibilities. Then "Qualifications" for Education and experience etc. Then "Skills" maybe for specific skills like proficiency with Veeva Vault, AI-assisted tools, publication planning, etc. Then "Benefits" for benefits description. Then "Pay" for salary range. "Schedule" not present, so omit.
We must not include filler like "commensurate with experience". The salary range is specific: $199,000 - $258,000 USD. That's specific, so include Pay section.
Benefits: they gave description but note "Benefits vary by location". That's somewhat vague but still they gave some specifics: Competitive health and wellness coverage, Paid time off, public holidays, additional leave entitlements, Flexible work arrangements / hybrid schedule. That's substantive enough. So include Benefits.
We must remove EEO boilerplate etc.
We need to output only HTML fragment, no /, no markdown fences.
We'll produce something like:
About the role
Job Summary ...
But we need to include the company overview? Might be part of About the role? Could add a paragraph about Beeline Medicines before job summary. The instruction: "Do NOT repeat the job title as a heading (the page already shows it)". It doesn't forbid including company overview. So we can include it in About the role. Let's extract the Job Summary paragraph: "The Director, Medical Writing is a hands-on leadership role responsible for clear scientific messaging and for the development, coordination, and delivery of high-quality regulatory, nonclinical, clinical, and other scientific documents in support of the company's I&I pipeline. This position combines active document authorship with functional leadership of medical writing, ensuring that deliverables meet high standards of scientific accuracy, regulatory compliance, and clarity. The Director owns the design and implementation of medical writing processes, templates, and standards, builds and manages internal writing capability, and directs the selection, oversight, and performance of external writing vendors within an agreed budget. The role partners closely with Clinical Development, Regulatory Affairs, Biostatistics, Medical Affairs, and external vendors to plan, author, review, and deliver documents supporting critical regulatory milestones, including INDs, amendments, briefing packages, and selected NDA/BLA components. This role is expected to remain closely involved in the hands-on execution of core documents while carrying accountability for people management, vendor and budget management, and delivery across multiple concurrent programs as submission activity expands." We can keep that. Then About Beeline Medicines paragraph: "Beeline Medicines is a clinical‑stage biotechnology company focused on developing and delivering category-leading precision therapies to transform the lives of people living with autoimmune and inflammatory diseases. With a portfolio of potential best-in-class and first-in-disease therapeutic candidates that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing medicines that have the opportunity to provide durable, life-changing impact. Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully." We could put that before the Job Summary in About the role. Now Responsibilities: list of duties. We need to convert to- . The responsibilities are a long paragraph with many items separated by periods. We need to extract each duty as list items. Let's parse:
"Own day to day execution of medical writing activities, authoring, coordinating, and reviewing key clinical and regulatory documents, including protocols and amendments, CSRs, IBs, SAPs, ICFs, INDs/CTAs, and selected BLA/NDA components, ensuring scientific accuracy, regulatory compliance, and consistency of content."
"Contribute to defining the strategy for submission narratives and key messages, leading scientific messaging consistency across CTD modules."
"Represent Medical Writing in cross functional and governance forums and drive alignment on submission strategy and document readiness."
"Direct planning and sequencing of document deliverables with Clinical Development, Nonclinical, Biostatistics, Safety, and Regulatory Affairs; own integrated timelines and trackers across concurrent programs, coordinate cross functional review cycles, anticipate and mitigate bottlenecks, and provide regular, transparent status updates to cross functional teams and leadership."
"Manage and develop medical writing staff and contract writers"
"Manage medical writing vendors, including selection, scope definition, deliverable tracking, quality oversight, and performance review."
"Own the Medical Writing budget and forecast internal FTE and vendor capacity against the program plan."
"Establish, document, and maintain the process for authoring, review, QC, and approval of regulatory documents submitted to health authorities, including SOPs, style guides, and templates aligned with ICH and regional requirements."
"Develop and deliver training to the cross functional team to ensure adoption of the agreed process."
"Support Health Authority briefing documents, meeting request packages, and written responses to Agency queries."
"Manage the Medical Writing function budget and resource planning, including FTE capacity and vendor utilization forecasting."
"Perform other duties and responsibilities as assigned."
We can make each bullet.
Now Qualifications: includes Education, experience, etc. We'll need to list as
- . Let's extract:
"Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required."
"Minimum of 10+ years of medical writing experience in the pharmaceutical or biotech industry,"
"Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages."
"Deep scientific expertise in immunology, inflammation, or autoimmune disease is preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas."
"Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment."
"Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards."
"Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment."
"Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault or equivalent."
"Strong publication planning experience, including familiarity with ICMJE authorship guidelines, journal submission processes, and scientific congress submission requirements."
"Proficiency with AI-assisted authoring and review tools applied to regulatory and clinical documents is strongly preferred, including practical understanding best prompt practices, limitations, quality control requirements, and appropriate use in a regulated environment."
"Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable."
"Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning."
"Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities."
"Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners."
"Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams and board-level stakeholders."
We could split into Qualifications and Skills sections. The instruction includes Skills as a possible heading. So we could put some of the skill-based items under Skills: proficiency with Veeva Vault, AI-assisted tools, publication planning, communication skills, presentations, etc. The rest under Qualifications: education, years experience, expertise, ability to manage, knowledge of regulations, experience developing SOPs, experience building/scaling function, leadership ability, influencing, etc.
But we need to avoid thin sections. Perhaps combine Qualifications and Skills into one Qualifications section? But we have both headings allowed. We could make Qualifications for education/experience/knowledge, and Skills for technical proficiencies. That seems reasonable.
Let's decide:
Qualifications (
Qualifications
) containing: - Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required. - Minimum of 10+ years of medical writing experience in the pharmaceutical or biotech industry - Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages. - Deep scientific expertise in immunology, inflammation, or autoimmune disease is preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas. - Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment. - Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards. - Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment. - Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable. - Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning. - Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities. Skills (Skills
) containing: - Proficiency with document management systems, electronic submission tools, and publishing platforms such as V
- . Let's extract:
"Education: Advanced degree (PhD, PharmD, or master's level) in life sciences, pharmacology, biomedical sciences, or a related discipline required."
"Minimum of 10+ years of medical writing experience in the pharmaceutical or biotech industry,"
"Extensive experience authoring and overseeing regulatory submissions in ICH CTD format, including CSRs, ISS/ISE, IBs, and IND/CTA packages."
"Deep scientific expertise in immunology, inflammation, or autoimmune disease is preferred, with the ability to rapidly acquire technical knowledge in new therapeutic areas."
"Demonstrated ability to manage multiple concurrent document deliverables and writing teams in a high-priority regulatory environment."
"Thorough knowledge of FDA and EMA regulatory writing requirements, ICH E3, E6, E8, and M4 guidelines, and applicable pharmacovigilance documentation standards."
"Experience developing and enforcing Medical Writing SOPs, style guides, and document templates in a regulated pharmaceutical environment."
"Proficiency with document management systems, electronic submission tools, and publishing platforms such as Veeva Vault or equivalent."
"Strong publication planning experience, including familiarity with ICMJE authorship guidelines, journal submission processes, and scientific congress submission requirements."
"Proficiency with AI-assisted authoring and review tools applied to regulatory and clinical documents is strongly preferred, including practical understanding best prompt practices, limitations, quality control requirements, and appropriate use in a regulated environment."
"Experience building or scaling a Medical Writing function in an early-stage or rapidly growing biotech organization is highly desirable."
"Demonstrated ability to lead, mentor, and develop cross-functional teams in a fast-paced, resource-constrained biotech or pharmaceutical environment; fosters a culture of accountability, inclusion, and continuous learning."
"Proven track record of influencing without authority across organizational boundaries, driving alignment among senior stakeholders, and building consensus on complex scientific or operational priorities."
"Exceptional written and verbal communication skills with demonstrated ability to translate complex scientific, regulatory, or operational content for diverse audiences, including executive leadership, clinical teams, and external partners."
"Skilled at preparing and delivering compelling presentations, briefing documents, and strategic updates to cross-functional leadership teams and board-level stakeholders."
We could split into Qualifications and Skills sections. The instruction includes Skills as a possible heading. So we could put some of the skill-based items under Skills: proficiency with Veeva Vault, AI-assisted tools, publication planning, communication skills, presentations, etc. The rest under Qualifications: education, years experience, expertise, ability to manage, knowledge of regulations, experience developing SOPs, experience building/scaling function, leadership ability, influencing, etc.
But we need to avoid thin sections. Perhaps combine Qualifications and Skills into one Qualifications section? But we have both headings allowed. We could make Qualifications for education/experience/knowledge, and Skills for technical proficiencies. That seems reasonable.
Let's decide:
Qualifications (