Senior Medical Writer

Senior Medical Writer / REMOTE / Contract  

About our Customer:

Our direct customer, a global Fortune 500 company & a leader in the Pharmaceutical industry is looking for a Senior Medical Writer.  The successful candidate should provide medical writing of clinical regulatory documents supporting components across various types of regulatory filings, including but not limited to: Investigator’s brochures, Protocol & Protocol Amendments, CSR, Agency Background Packages and Response to Agency Inquiry, clinical modules of INDs, NDAs, BLAs, MAAs and other regulatory submissions, and other types of clinical and regulatory documents within the working scope of medical writing.

Required Experience and Skills:

• At least 7 years of medical writing experience in pharmaceutical industry.
• Experience as lead writer for key documents included in major EU and/or international regulatory submissions required.
• Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
• Understanding of FDA/international regulations, ICH guidelines, and applicable international regulatory processes related to document preparation and production (including CTDs).
• Must have proven track record to be able to think critically, strategically, independently and solve problems.
• Must have high level of motivation, drive, and demonstration of our new company''s leadership values.
• Excellent time and project management skills.
• Excellent written and verbal communication skills including the ability to write clearly and concisely.
• Top notch interpersonal skills in difficult situations.
• Ability to collaborate across multiple functional areas.
• Bachelor of Science Degree in Life Sciences or Health Care Professions (Nursing/ Pharmacy) or related discipline. Or Master’s degree / PhD / PharmD preferred.

Responsibilities:

• Manage the assigned writing tasks and ensures that the documents adhere to relevant regulatory guideline(s), as well as Organon’s SOP/WI(s), template(s), and style guide.
• Manage multiple documents at the same time, and ensures timely and high-quality completion of Medical Writing deliverables that include the proper content and context and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• Initiate and lead strategy/resolution meetings when required
• Drive interaction and clear handoffs between stakeholder organizations (Clinical, Safety, Regulatory, Non-Clinical) to the MW team.
• Support and drive partnering with vendors to provide Medical Writing support.
• Contribute to the development, alignment, and consistent implementation of processes.
• Responsible for following processes and being inspection-ready.
• Contribute to the preparation/revision of document templates, development of process, and preparation/revision of standard operating procedures (SOPs) and guidance documents.
• Develops and drives process supporting content authoring, quality assurance and formatting to a standard within the global content authoring platform.
• Participates in Clinical Research Organization (CRO) alliance and other outsourcing activities, if required.