Senior Medical Writer – Oncology & Regulatory Submissions

Catalyst Clinical Research; España; Sur place; USD 100 000 - 130 000; Plein temps

Résumé du poste

A biotechnology research company is seeking a Principal Medical Writer to deliver high-quality clinical and regulatory documents. This role involves collaborating with cross-functional teams, managing document preparation, and ensuring compliance with ICH guidelines. Candidates must have substantial experience in medical writing, particularly in oncology, and demonstrated project management skills. Flexibility and independence are key, as well as strong communication and interpersonal skills. This is a full-time position offering mid-senior level responsibilities.

Qualifications

• 12+ years with a Bachelor's degree, 7+ years with a Master's, or 5+ years with a Doctoral degree in medical writing.
• Experience writing INDs, Clinical protocols, and regulatory documents.
• Ability to meet timelines in a virtual R&D organization.

Responsabilités

• Prepare and finalize scientific documents including clinical study reports.
• Manage document review processes and clarify comments.
• Collaborate with clinicians and biostatisticians.

Connaissances

Clinical research knowledge

Interpersonal skills

Project management

Attention to detail

Ability to work independently

Formation

Doctoral Degree in relevant field

Master’s Degree

Bachelor’s Degree

Outils

EndNote

MS Word

Description du poste

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries through Catalyst Oncology, a full-service oncology CRO,andmulti-therapeutic global functional and CRO services through Catalyst Flex. The company's customer-centric flexible service model, innovative technology, expert team members, and global presence advance clinical studies. Visit CatalystCR.com.

As a Principal Medical Writer, you will collaborate with members of cross-functional teams to prepare (or oversee preparation by contract service providers) high-quality protocols, protocol amendments, investigator brochures, synopses, Clinical Study Reports, regulatory documents such as INDs and BLAs, clinical publications, and related clinical documents within agreed-upon timelines.

Key Essential Functions

• Prepares, edits, and finalizes protocols, investigator brochures, synopses, Clinical Study Reports, pre-IND, IND, NDA submissions, other regulatory documents and related scientific documents, such as abstracts, posters, presentations, and manuscripts, integrating inputs from other team members into a cogent fit-for-purpose whole.
• Participates in scientific communication planning, including development of strategic medical communication plans
• Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
• Manages all aspects of outsourced or internal deliverable production and ensures project delivery
• Partners with other clinical team members including participation in the review of mock and/or blinded tables, figures, and listings (TLFs), and narrative planning for relevant documents
• Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
• Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
• Works closely with QA to maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
• Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
• Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
• Conduct client/KOL interactions, kickoff meetings, and teleconferences as needed covering various time zones in an effective manner.
• Act as project lead/delivery lead for assigned client and responsible for healthy partnership for each account.
• Support proactively in trainings & department operation activities as needed.
  
  

Required Skills & Abilities

• Must have a thorough knowledge of clinical research concepts, practices, and FDA/EMA/other regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
• Broad experience managing the medical writing responsibilities associated with multiple studies at various stages and across various functional teams
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure in a virtual R&D organization; adapt to change as needed; possess excellent project management skills; attentive to details
• Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
• Ability to communicate scientific or medical information in a clear and concise manner
• Track record of increasing responsibility and independence in a similar role in pharmaceutical drug development
• Excellent organization skills with acute attention to detail
• Strong computer skills, including use of EndNote/ equivalent software within MS Word and other tools for MW activities
  
  

Required Qualifications

• Bachelor’s degree +12 years, Master’s Degree +7 years, Doctoral Degree +5 years of relevant medical writing experience in the pharmaceutical industry, especially writing in oncology; graduate degree (masters or doctoral) preferred.
• Proven successful experience with writing INDs, Clinical protocols, Clinical study reports, Investigator Brochures, regulatory correspondence and documents, and/or NDAs/BLAs, and peer-reviewed journal articles.