Medical Writer/Sr. Medical Writer (Remote)

For Med Writer - 100-115K target

For Sr. Med Writer - 115-125K (127K is the max here)- leveling determined when they assess the candidate.

They are looking for someone to primarily write clinical content, able to contribute/manage/write documents to go to the agency DIND, IND, protocols, investigator brochures. Experience with clinical protocol writing, at least 3 years, investigator brochures and other study documents and then in a minor role - able to help the CMO or Chief Business offer with clinical abstracts, posters, presentations to the market (for wall street, investors, etc.). They are pursuing 2 indications at the moment, as they get through phase II may be expanding to other indications, so NDA experience is helpful. Really want them to have Oncology experience, doesn't matter if it's heme, could be solid tumor.

SUMMARY OF RESPONSIBILITIES:

The Medical Writer role will collaborate with internal and external key team partners to develop clinical documents, abstract and publications that are aligned with the Company objectives. This is a hands-on position that primarily includes writing and critically editing scientific manuscripts, abstracts, and podium presentations.

PRIMARY RESPONSIBILITIES:

· Generate content in collaboration with authors/collaborators for protocols, investigator’s brochure, clinical study reports, safety updates, abstracts, posters, orals, manuscripts, and slide sets working from various data sources

· Performs Quality Control checking and proof reading of all required documents to meet customer expectation

· Manage multiple documents across different molecules/projects and obtain feedback from all key partners to define and implement documents strategies

· Appropriately communicates the scientific significance and value of all documents to the target audience, consistent with business processes and compliance requirements

· Understand and use product strategy, communication objectives, and lexicon appropriately to ensure alignment with publication content

· Maintain relationships with internal and external collaborators/authors on assigned documents and supports process improvement

· Understand the publication landscape (e.g., journals, congresses, readership) and advise key stakeholders accordingly

· Support documents and publication strategies and prioritization of documents and publications

· Drive documentation project timelines and handle multiple projects at a time; may support one or more products

· Ensure quality, alignment with objectives, and timely completion of publications while staying on track with allocated budgets

· Draft and edit abstracts, posters, and slide decks for presentation at scientific and medical congresses.

· Establish, maintain, and expand business relationships with cross-functional team members collaborating on publication projects to ensure accurate and timely completion/delivery of information based on publication plans.

· Management of CRO medical writing relationship with regard to all protocol documents, FDA filings, and site communications like memos or addendums.

· Maybe responsible for training, mentoring or supervising junior staff members

· Other duties as assigned.

REQUIRED EDUCATION & WORK EXPERIENCE:

· Minimum Bachelor’s Degree in a scientific field of study. Advance degree strongly preferred (MS, PhD, MD, PharmD, etc.).

· Minimum 5+ years of direct scientific writing experience or 3+ years’ experience with advanced degree.

PREFERRED QUALIFICATIONS:

· PhD, MD, or PharmD with at least 3-5 years of clinical documentation and publication development experience for industry in the bio-pharmaceutical sector

· Experience preparing clinical research documents, and manuscripts for publication in peer-reviewed medical journals as well as abstracts and posters or oral presentations for scientific congresses

· Experience working in a matrix team setting

· Experience collaborating with clinical investigator authors/collaborators on documents and publication development

· Exceptional analytical, communication, organizational, and interpersonal skills

· Ability to apply project management skills to advance numerous projects at a time and to deliver high-quality documents rapidly

· Ability to lead and/or facilitate effective team meetings for deliverables

· Proficient in word processing and pertinent software (e.g., Microsoft Office, EndNote)

· Knowledgeable about ICMJE (International Committee of Medical Journal Editors) and GPP3

· Good Publication Practices 3 guidelines

FUNCTIONAL / TECHNICAL KNOWLEDGE & SKILLS:

· Knowledge of cGMP requirements for pharma / biotech industry

· Small molecule drug development

· Regulatory environment

· Process, procedures and best practices

· Proficient in Microsoft Office (Word, Excel, and Power Point) and Smartsheet