Senior Manager, Medical/Regulatory Writer

Scorpion Therapeutics; Radnor (Delaware County); On-site; USD 158,000 - 185,000; Full time

Job summary

Scorpion Therapeutics seeks an experienced Medical Writer to lead regulatory writing for programs from first-in-human to registration. You will coordinate cross-functional teams to ensure consistent, high-quality submissions and contribute to regulatory messaging strategy.

The role includes authoring or supervising preparation of regulatory documents (protocols, CSRs, briefs), and authoring CSRs. You will manage internal/external writing processes and input into IND/CTD materials, ensuring

Qualifications

• Track record writing medical research documents (protocols, CSRs, health authority briefings).
• MS Word (macros/templates) and Adobe Acrobat (bookmarks/hyperlinks).
• Understanding of global regulatory requirements; experience supporting global clinical programs.
• Agile to changing priorities; leadership, communication, attention to detail, organization.
• Maintain document inventory/tracking in eDMS/RIMS.

Responsibilities

• Lead and oversee medical/scientific regulatory writing for assigned programs from first-in-human through product registration.
• Coordinate cross-functional writing to ensure consistency and quality; provide writing support and contribute to regulatory messaging strategy.
• Author or supervise preparation of regulatory documents for health authority submissions, including: clinical study protocols, clinical summaries (clinical overview, ISS/ISE, PK/PD summary, AC briefing), Investigator Brochure(s), DSURs, briefing documents, responses to health authority questions, and other submission materials.
• Author clinical study reports (CSRs).
• Manage internal/external writing processes; resolve errors/inconsistencies; ensure timely, high-quality deliverables.
• Coordinate external (contract) writers.
• Input into regulatory submission documents (e.g., IND/CTA materials, labeling, CTD/BLA/MAA for eCTD).
• Contribute to medical writing procedures/best practices; maintain controlled archival files.
• Perform assigned QC review (grammar, formatting, clarity, etc.).

Skills

Medical writing

Regulatory knowledge

MS Word

Adobe Acrobat

Project coordination

Education

BS in life sciences or related field

Advanced degree (MS/PhD/MD)

Tools

MS Word

Adobe Acrobat

Job description

Responsibilities:

• Lead and oversee medical/scientific regulatory writing for assigned programs from first-in-human through product registration.
• Coordinate cross-functional writing to ensure consistency and quality; provide writing support and contribute to regulatory messaging strategy.
• Author or supervise preparation of regulatory documents for health authority submissions, including: clinical study protocols, clinical summaries (clinical overview, ISS/ISE, PK/PD summary, AC briefing), Investigator Brochure(s), DSURs, briefing documents, responses to health authority questions, and other submission materials.
• Author clinical study reports (CSRs).
• Manage internal/external writing processes; resolve errors/inconsistencies; ensure timely, high-quality deliverables.
• Coordinate external (contract) writers.
• Input into regulatory submission documents (e.g., IND/CTA materials, labeling, CTD/BLA/MAA for eCTD).
• Contribute to medical writing procedures/best practices; maintain controlled archival files.
• Perform assigned QC review (grammar, formatting, clarity, etc.).

Supervision:

• No direct supervisory responsibilities; oversee/coordinate external writers.

Essential Qualifications/Skills:

• Track record writing medical research documents (protocols, CSRs, health authority briefings).
• MS Word (macros/templates) and Adobe Acrobat (bookmarks/hyperlinks).
• Understanding of global regulatory requirements; experience supporting global clinical programs.
• Agile to changing priorities; leadership, communication, attention to detail, organization.
• Maintain document inventory/tracking in eDMS/RIMS.

Preferred:

• Master/sub protocols, umbrella trials, basket studies.
• Short-turnaround RFI responses.
• Experience with eDMS/RIMs and review/collaboration systems.

Education:

• BS with 4–7 years medical/regulatory writing and 7–10 years industry experience; or advanced degree (M.S., PharmD, Ph.D., M.D.) with 3–5 years.

US Salary Range:

$158,000–$185,000.