Medical Writer

Discover International is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols, clinical study reports, manuscripts, conference abstracts, and posters. This is a key position within CNS scientific communication with ample opportunity to make real impact. The medical writer reports to the Head of Clinical Development, with a dashed dotted line to the Medical Affairs/HEOR lead as applicable.

Job Responsibilities and Duties include, but are not limited to, the following:

Interpret complex data and develops high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, publications and other documents in support of Medical Affairs, RWE/HEOR and/or Clinical Development programs
Attends strategic meetings as applicable
Closely collaborates with, and apply applies strategic direction from, project and publication leads, and biostatisticians in order to manage and prioritize assignments to ensure deliverables are completed per time and quality goals
Previous experience with preparation and QC of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus
Develops documents for assigned programs in compliance with company standard operating procedures (SOPs). (Previous experience with preparation and QC of various document types: core clinical documents (protocols, IBs, CSRs, etc.), Health Authority Submission documents (Agency Briefing Documents, eCTD Summary Documents, Orphan Drug Applications), etc is a plus)
Develops documents for assigned programs in compliance with company standard operating procedures (SOPs)
This may include developing timelines, review/approval workflow management, and/or QC/publication readiness
Works with cross-functional internal teams to ensure wide acceptability of documents and consensus of content
Oversees outsourced medical writings projects and the associated vendor(s), as applicable
Critically analyzes, synthesizes, and presents complex information
Drives Results
Ensures Accountability

Requirements / Qualifications

Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 5-8 years relevant experience
A strong current working knowledge of the pharmaceutical environment is required.

Experience and Knowledge:

Highly knowledgeable in the relevant disease areas
Track record of developing high-quality scientific documents
Ability to interpret, evaluate, and communicate (in a variety of formats and styles) complex scientific and clinical data
Expertise in use of online and other data sources for literature searches and information
General knowledge of the drug development and approval processes and GXP principles
Ability to work with cross-functional executive leadership and exposure to sensitive information, necessitating considerable use of tact, diplomacy, discretion, and judgment
Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables
Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment
Flexible and able to adapt to changing deadlines and priorities
Excellent written, verbal, and interpersonal communication skills
Highly attentive to detail
Able to self-manage effort to maintain alignment with strategy and corporate goals

Great hourly rate + Additional benefits + Free NFL / NBA / MLB game ticket for successful candidates!