Principal Medical Writer remote

Clinical Research Medical Writers Snr Manager And Principal Level Medical Writers

The Medical and Scientific Writing group has needs for Clinical Research Medical Writers Snr Manager and Principal level medical writers with experience writing clinical documents. Each will be an active contributor/lead author of regulatory and scientific documentation, will manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international governmental regulations, will mentor junior writing staff, and will manage external vendor writers’ deliverables.

Document examples include but will not be limited to clinical protocols, clinical study reports, investigator’s brochures, and clinical sections of investigational new drug applications and marketing applications. Strategic regulatory documents such as agency responses and briefing packages will also be managed. The manager will be responsible for the creation of English-language medical writing deliverables, ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards.

Specific Responsibilities:

• Ensure that clinical regulatory documents accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of clinical data are maintained from concept to licensing and disclosure.
• Perform activities (with minimal supervision) including editing, writing, development of timelines, project management, and participation on project teams.
• Serve as the main medical writing contact on study teams contributing to a variety of clinical documents, including clinical protocols, clinical study reports, investigator’s brochures, and regulatory submissions.
• Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.
• Ensure that deliverables meet all applicable regulations, standards, and guidelines, including ICH guidelines.
• Mentor and manage the work of junior writers as needed.
• Manage the work and deliverables of contract/vendor writers, as needed.
• Participate in the preparation of responses to questions from regulatory agencies and write briefing packages, other strategic regulatory documents such as accelerated review applications, and assist with materials for presentations at agency meetings and advisory committee meetings as needed.
• Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs. Work cross-functionally to update procedures or practices as needed to remain within regulatory compliance and to improve internal quality and efficiency.

Skills and

Education:

Mandatory:

• Advanced degree in a relevant scientific/clinical/regulatory field preferred;
  Bachelor’s degree required.
• 7-10 years of medical writing experience (dependent upon graduate degree)
• Experience as a lead writer/medical writing point of contact for marketing applications (NDA/BLA)
• Global regulatory submission experience
• Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
• Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed and critically evaluate the outsourcing strategy.
• Demonstrated ability to remain flexible should priorities change (judgment and decision making) during project execution.