[Hiring] Senior Manager, Medical Writing @Alfasigma

Role Description

As we continue to grow, we are seeking a Sr. Manager, Medical Writing. This is a remote based position and can be in Europe or on the East Coast of the US.

The Senior Manager, Medical Writing, leads authoring of complex documents for one or more clinical development programs.

• Leadership:
  • Train junior medical writers on best practices in medical writing and regulatory submission processes.
  • Help oversee vendor partnerships.
• Writing:
  • Lead author (including content planning, writing, and review) for clinical study protocols, clinical study reports (CSRs), investigator brochures, and other study-level documentation required for clinical trials.
  • Author individual modules of IND/CTA, NDA, MAA requests for information and briefing documents for regulatory agencies.
  • Review Summary of Clinical Efficacy (SCE) and Summary of Clinical Safety (SCS) statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
• Quality Control:
  • Coordinate for the quality and compliance of written components to company standards as well as regulatory requirements.
• Project Management:
  • Create document timelines and coordinate reviews with cross-functional teams and contract research organizations (CROs).
  • Manage vendor/contract medical writers.
• Collaboration:
  • Collaborate with cross-functional teams to analyze complex scientific data for the above-mentioned document types.
  • Lead the document review process for study-level, submission, and regulatory interaction documents, through management of timelines, scheduling of meetings, and incorporation of feedback from cross-functional teams.
  • Represent Medical Writing on Clinical Study Team(s) (CST[s]).
• Literature Reviews:
  • Conduct thorough literature reviews and synthesize complex scientific data into clear and concise documentation.
• Department Administration:
  • Oversee quality and adherence to document templates and standard operating procedures (SOPs).
• Regulatory Standards:
  • Ensure all documents adhere to regulatory guidelines, formatting standards, and internal quality standards.
  • Maintain up-to-date knowledge of industry trends and regulatory changes and provide oversight to ensure that standards are being applied through review of documents produced by other team members.

Qualifications

• Bachelor's degree in life sciences with minimum 8 years’ relevant experience in medical writing or pharmaceutical industry and/or clinical research OR
• Advanced scientific degree (MS, PhD, Pharm D) with a strong background in relevant scientific discipline with minimum 5 years of relevant experience in medical writing or pharmaceutical industry and/or clinical research.
• Experience supporting and/or leading individual components of INDs, NDAs, and MAAs, as well as briefing books.

Requirements

• Strong verbal and written communications skills coupled with general knowledge of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies and regulatory documents.
• Detail-oriented, with good organizational, prioritization, and time management proficiencies; proactive approach.
• Ability to work cross-functionally.
• Advanced computer software experience (including but not limited to MS Word, Excel, PowerPoint).
• Ability to interpret and present scientific and clinical trial data and understand statistical methods and analysis plans.
• Proven ability to facilitate issue/comment resolution as it relates to finalization of medical writing deliverables.
• Ability to thrive and adapt in times of uncertainty.

Benefits

• Competitive salary.
• Comprehensive benefits.
• Extensive opportunities for professional growth and development.