The Medical and Scientific Writing group has needs for Manager, Snr Manager and Director level – 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.
• The Medical Scientific Writing Professional (DOE) will ensure that clinical regulatory documents (eg, study reports, study protocols, clinical summaries/overviews, investigator’s brochures, scientific publications, contributions to response documents, and other global regulatory submission documents as appropriate) 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.
• Activities (performed with minimal supervision) will include, but will not be limited to editing, writing, development of timelines, project management, and participation on project teams.
• Will 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.
• Will coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents
• Will ensure that deliverables meet all applicable regulations, standards, and guidelines, including ICH guidelines.
• Will mentor and manage the work of junior writers as needed.
• Will manage the work and deliverables of contract/vendor writers, as needed.
• Will 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.
• Will maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs. Will 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:
• 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.
The applicant must demonstrate:
• Excellent verbal and written communication skills
• Exceptional organizational skills and attention to detail
• Project management skills (MS Project experience preferred) and familiarity with GCP and ICH guidelines
• Technical skills with relevant software for authoring such as MS Word
The applicant must be able to:
• Manage multiple projects with competing priorities
• Work within a study team with minimal supervision
• Work in a global team environment with ability to maintain strong relationships with the global medical writing management and local US MW, Biometric management
• Expertise with lay summeries and systematic literature searching
• Minimal 5+ years of experience in clinical/pharmaceutical development as a medical writer