Senior Medical Writing Director, Regulatory Submissions

Supernus Pharmaceuticals Inc; United States; On-site; USD 166,000 - 193,000; Full time

Benefits offered by this job

Stock equity awards

Employee stock purchase program

Discretionary annual bonus

Health and wellness benefits

401k company match

Job summary

Supernus Pharmaceuticals is seeking an Associate Director of Medical Writing to provide leadership and oversight for multiple programs reporting to the Head of Medical Writing. You will independently plan, lead, and develop content for clinical/regulatory documents to support regulatory filings.

Responsibilities include strategic input on document development, SME leadership, and authoring a range of documents, including protocols, CSRs, IBs, annual safety reports, abstracts, manuscripts, and

Qualifications

• Bachelor’s in physical or life science required with a minimum of 8+ years of experience or a Master’s degree with a minimum 6+ years of relevant medical writing and project management experience.
• PhD degree is highly desirable with a minimum of 5+ years relevant work experience in pharmaceutical companies or CROs.
• Experience in clinical research or medical/clinical writing, in a pharmaceutical or CRO is preferred.
• Demonstrated direct clinical regulatory writing experience in a pharmaceutical, biotech, or CRO space.
• Demonstrated experience in being able to lead, collaborate, and manage people.
• Strong understanding of Microsoft Office.
• Experience in Veeva Vault document management.
• Working knowledge of medical terminology.
• Familiarity with relevant regulatory guidance especially ICH E6 and E3.

Responsibilities

• Provides strategic input into program-level plans for document development and authoring, deliverable level timelines to meet program goals.
• Provides leadership and guidance at the team level as an SME for document scope and content.
• Contributes strategically and scientifically at the study team level with recommendations for data reviews, collection of specific data, data outputs, and document content.
• Proactively advise study and submission teams regarding regulatory requirements and ICH guidance for clinical documents.
• Aligns, coordinates, and builds consistent information and messages across clinical program(s) for deliverables.
• Independently plans, manages, and authors routine and complex documents in support of the clinical development program and submissions (clinical synopsis/protocols, CSRs, Investigator brochures, ASRs, abstracts/manuscripts, NDA/BLA/IND/CTA/SOPs).
• Reviews and provides oversight of documents prepared by outside contractors for content, clarity, accuracy, consistency, and alignment with company position.
• Proactively anticipates risks, provides solutions, and mitigates risks; manages stakeholder expectations.
• Participates in goals/initiatives for the MW department and implements new technologies at the enterprise level.

Skills

Leadership

Project management

Regulatory writing

Team management

ICH E6/E3

Veeva Vault

MS Office

Medical writing

Clinical development

CRO experience

Stakeholder management

Education

Bachelor's in physical or life science

Master's degree

PhD degree

Tools

Veeva Vault

Job description

Supernus Pharmaceuticals is seeking an Associate Director of Medical Writing to provide leadership and oversight for multiple programs reporting to the Head of Medical Writing. You will independently plan, lead, and develop content for clinical/regulatory documents to support regulatory filings.

Responsibilities include strategic input on document development, SME leadership, and authoring a range of documents, including protocols, CSRs, IBs, annual safety reports, abstracts, manuscripts, and