Full time, Central NJ
This position will be responsible for writing, reviewing, and publishing manuscripts in peer-reviewed journals in support of ongoing programs. This position may also contribute to compositions of analyses and documentation needed for submissions to regulatory authorities.
The ideal applicant would have training in the biomedical research sciences, particularly in areas such as biology, pharmacology, chemistry, and biotechnology. Additionally, the applicant would have previous experience writing manuscripts for publication. A minimum of 5 years of writing experience for a pharmaceutical company is preferred. A good understanding of medical terminology and AMA style writing is needed. A graduate degree (PhD, PharmD or equivalent with 5-10 years of writing experience or a Masters degree with at least 10 years of writing experience is required.
This position requires translating technical information from mixed sources into written information suitable for an audience of regulatory authorities, clinicians, or researchers in the field. It will be essential to approach issues from a number of perspectives to summarize data to draw conclusions. The applicant must be able to prepare deliverables in accordance with pre-established timelines and specifications, systematically performing activities in a timely and accurate manner.
Advanced writing and speaking competency, positive and proactive communication skills, proficiency with Microsoft Office Suite, and high attention to detail are expected. The candidate must be able to work independently and efficiently with cross functional team members.
Experience authoring manuscripts is necessary.
Responsibilities may include but are not limited to:
- Authoring of manuscripts and abstracts in a clear and accurate manner consistent with the target audience, regulatory requirements, and journal specifications
- Analyze, interpret, and accurately present data in text, table, or figure format, as needed
- In collaboration with other functional areas, contribute to regulatory submissions by authoring relevant sections of eCTDs (eg, ISS, ISE, Clinical Overview)
- Quality-checking documents for agreement between in-text information and the source data
- Editorial review of documents for grammar, punctuation, and submission-compliant formatting
Reliance on instructions, templates, and pre-established guidelines will be expected to perform the above functions. The applicant will work under the immediate supervision of the Manager, Medical Writing.
Candidates must be able to commit to working 5 days a week on site at the client’s Central NJ location.
Contact information for job applicants, to be included in posting: Laura Walton, firstname.lastname@example.org, 732-447-1659