Medical WriterClinical III (Senior)

• Bachelor of Science Degree in Life Sciences or Health Care Professions (Nursing/ Pharmacy) or related discipline.
• Master s degree / PhD / PharmD preferred.

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 US/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 US/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 companys 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.

Responsibilities:

• This role is accountable for Medical Writing (MW) and is part of the Regulatory Operations organization.
• The successful candidate should expect to 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.
• This position will be for a member of the Medical Writing Team reporting into the Head of Medical Writing.

Primary 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.