Large US hub for one of either Astellas/Takeda/Eisai (need mutual NDA in place for LifeSciHub to disclose).
Head of Non Clinical Writing and Submissions needing senior MW expertise for writing, QC, lifecycle management, and providing input, guidance and mentoring for less senior members of the team.
Hours and duration- to be determined. At present the need is to find the right expert, then will work from there. If full time hours are available, that might work very well. If less than full time hours are available, and it’s a good fit, sponsor will work around your availability.
Looking for extensive background in tox, pk, regulatory documents, summaries. Sponsor products cover a variety of modalities in several therapeutic areas. . Can write SOPs as well if needed. Work is both early development and post marketing, from briefing books to submissions.
8 years or more experience, preferably global experience. Need a deep understanding of the regulatory landscape and regulatory strategy- sufficient to be able to work closely with the regulatory strategists themselves. Need deep scientific understanding, PhD or equivalent demonstrated experience preferred, because “Scientists like to talk to other scientists.”
This is not a single project or submission, they are looking for someone who will be part of the team, function as an FTE from a sense of ownership and commitment standpoint, Looking for an ongoing relationship.
Technologies involved- PleaseReview, Documentum, homegrown eCTD templates, Veeva implementation pending.
Will add official sponsor “job description” shortly.
Hello members! I’ve received more information about this project. This is an excerpt from the sponsor’s official “job description”. For full information please message me about executing a LifeSciHub Mutual Non Disclosure Agreement, terms here: https://lifescihub.com/lifescihub-mutua…ment-version-1-3
Global sponsor TAs include: Oncology, Gastrointestinal, Neuroscience, Rare Disease.
POSITION OBJECTIVES:
• Manage, mentor, and develop a team of junior nonclinical writers. Lead or support training initiatives within the group and support maintenance of a balanced workload among nonclinical writers.
• Analyze, interpret and distill nonclinical data to independently manage a variety of projects of diverse scope and complexity across all developmental stages (pre-development through post-marketing) and [sponsor]’s major therapeutic areas (e.g., Oncology, Gastrointestinal, Neuroscience, Rare Diseases) while ensuring alignment with International Conference on Harmonization (ICH) guidelines, regulatory requirements and [sponsor]’s policies and processes.
• Lead the authoring and/or reviewing of preclinical and translational science documents (research study/project reports), nonclinical development documents (study reports) and the nonclinical sections (pharmacology, pharmacokinetics, and toxicology) in regulatory documentation supporting in-line, pipeline and late-stage programs.
• Provide support and guidance on the nonclinical regulatory strategy and requirements for regulatory interactions, when needed.
• Apply advanced knowledge of relevant scientific expertise, regulatory requirements, corporate policies, and work experience to assess document requirements and identify information gaps or other potential issues.
• Support [sponsor] Business and Center for External Innovation (CEI) by respectively and efficiently managing the documentation for nonclinical due diligence process, asset in-licensing and divestiture processes in compliance with [sponsor] processes.
• Represent NRWS on cross-functional teams, and work closely with Nonclinical Regulatory Writing team and other internal and external collaborators.
• Serve as the NRWS representative on cross-functional initiatives.
POSITION ACCOUNTABILITIES:
• Independently lead the planning, tracking, compilation, and regulatory compliance of nonclinical scientific and technical documentation.
• Manage all technical nonclinical content (study report, publications, etc.) across [sponsor]’s portfolio.
• In collaboration with the nonclinical regulatory writing team, support the nonclinical regulatory strategy and provide the nonclinical organization with information on the regulatory requirements as needed.
• Deep understanding of the scientific writing principles; writing with the audience in mind, and demonstrate an ability to conveying messages in a clear and concise manner.
• Work closely with SMEs to ensure appropriate input, review, and finalization of technical documentation activities in alignment with internal policies and processes, and regulatory requirements.
• Represent NRWS on cross-functional teams to plan, generate, manage, and finalize nonclinical documents. Generate nonclinical timelines.
• Liaise effectively with cross-functional team members to communicate aims, content requirements, internal [sponsor] requirements, and timelines.
• Learn and understand new therapeutic areas quickly and comprehensively.
• Support NRWS and [sponsor]’s innovation initiative, as needed.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
• Ph.D. in a scientific field (e.g., biology, pharmacology, toxicology), with a minimum of 10 years of experience with nonclinical and/or scientific writing within a pharmaceutical or Contract Research Organization (CRO) is a must.
• Experience in pharmaceutical or biotech product development across numerous modalities, with direct involvement in regulated studies related to pharmacology, toxicology, or pharmacokinetics, demonstrating a broad understanding of the drug development process.
o An experience in translational science is an advantage.
• Significant experience in direct authoring of technical reports (pharmacology, toxicology, pharmacokinetics) is a must.
o Experience with nonclinical summary sections to support regulatory submissions, including but not limited to IBs, briefing books, INDs, periodic reports, NDAs/MAAs/BLAs, and agency responses is highly preferred.
o Experience with regulatory submissions for new modalities (e.g.: cell therapies, gene therapies, microbiome) is an advantage.
• Demonstrate ability to prioritize, manage multiple programs within strict regulatory/compliance deadlines and lead internal/external and scientific teams to regulatory submission aims.
• Thorough understanding of regulatory guidelines related to global submissions and submission content (e.g., FDA/EMA/PMDA regulations; ICH guidance and familiarity with GLP/GCP requirements).
• Possess innovative problem-solving skills and ability to influence peers.
• Demonstrate critical thinking and attention to details.
Sheila here with an update on this project. Sponsor Hiring (HE) entity selected an excellent expert, but it ended up taking more than 3months to get through contracts. By then the expert had understandably moved on to other projects. I let the HE know that LifeSciHub wouldn’t be able to find them anyone else without additional attention to legal. They have now dedicated a specific legal resource to this effort, and we have a clear contracts pathway forward so this next selection should move very quickly.
8-2-2022 update- as this team has been operating understaffed for quite a while, they have now added a new permanent member of the team, a Technical and Scientific Writing Team Lead., starting Sept 12. This has not impacted their need for additional expertise. The scope, at the moment, is narrowed down from above, some of which the new FTE will take on.. Here are the current priorities:
Work closely with Nonclinical Regulatory Writing team lead and team members, and other internal and external collaborators, represent NRWS on cross-functional teams, and additional tasks below. Special emphasis/priority on the first two bullets:
• Provide scientific and writing support to develop and finalize templates for non-clinical specialties, such as DMPK, pharmacology, safety pharmacology and toxicology, where needed. Interact with SMEs as appropriate.
• Lead the authoring and/or reviewing of preclinical and translational science documents (research study/project reports), nonclinical development documents (study reports) and the nonclinical sections (pharmacology, pharmacokinetics, and toxicology) in regulatory documentation supporting in-line, pipeline and late-stage programs
• Apply advanced knowledge of relevant scientific expertise, regulatory requirements, corporate policies, and work experience to assess document requirements and identify information gaps or other potential issues.
• Serve as the NRWS representative on cross-functional initiatives.