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1+ months

Manager of Medical Writing

Kelly Services
Malvern, PA 19355
**Manager of Medical Writing**


Direct Hire with a Global Pharmaceutical Company (Remote Position)


Kelly Science and Clinical is hiring a Manager of Medical Writing for one of our global research-driven pharmaceutical companies to grow with their team. This opportunity is a permanent position and offers a competitive salary, strong benefit options, as well as Annual Bonus opportunities.


The Manager, Medical Writing prepares complex, high-quality clinical, regulatory, and safety documents in collaboration with cross-functional study teams, contributes strategically and scientifically at the project and/or study team level, manages and provides mentoring and support to other medical writers, develops and streamlines workflows and processes across clients research, and collaborates with internal and external stakeholders to support clinical/regulatory/safety documentation objectives in multiple therapeutic areas.


3+ years pharmaceutical or pharmaceutical Clinical Research Organization (CRO) medical writing experience is required. Regulatory writing experience is preferred.


**Responsibilities**


+ Writes, reviews, and edits clinical and/or regulatory documents (e.g., protocol, protocol amendments, preclinical and clinical study reports, Investigators Brochures, IB addendums, package inserts, clinical and non-clinical modules of INDs, NDAs, and MAAs, Briefing Books, annual reports, DSURs, IMPDs) and other documents in collaboration with cross-functional area teams and per the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), the National Institute of Health (NIH), and regulatory guidance/standards.

+ May also prepare publications (scientific manuscripts, abstracts, poster presentations, oral presentations).

+ Represents medical writing function as an integrated member of clinical study teams.

+ Drives document writing and review processes.

+ Develops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members

+ Coordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization

+ Collaboratively contributes to regulatory medical writing tasks across functional teams and projects, providing relevant guidance and direction for less senior medical writers as needed.

+ Develops and drives detailed project timelines according to team-specified deadlines per medical writing processes.

+ Works to develop regulatory document templates, formatting, and guidelines for clinical documentation.

+ Functions as a medical writing project manager/liaison between the medical writer team and nonclinical/clinical/regulatory cross-functional teams

+ Provides mentorship and training to the medical writers.


**Qualifications**


+ BA/BS required, preferably in a related scientific discipline.

+ Advanced scientific degree (MS, PharmD, PhD) is preferred.

+ 5+ years of healthcare experience is required.

+ **3+ years pharmaceutical or pharmaceutical Clinical Research Organization (CRO) medical writing experience is required.**

+ Hands-on Clinical Research experience is a plus.

+ Experience in a managerial or lead role, including project/resource allocation experience.

+ Ability to draw on broad expertise to recommend new company SOPs (or revisions to existing ones) to continually improve internal processes.

+ Outstanding team player. Can work as a leader and a member in a collaborative and supportive role; demonstrates leadership through assigning/managing the work of other writers and developing people through mentoring.

+ Knowledge of clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH, NIH), AMA writing style, use of Word templates, and familiarity with GCP guidelines. An attentive, fast learner who is willing to continue to gain regulatory MW expertise and implement MW and MTDA working processes and SOPs

+ Outstanding interpersonal, written, and oral communication skills, and ability to work in collaboration with a cross-functional study team, able to establish rapport with all functional leaders, experts, and colleagues

+ Ability to conceptually organize and analyze data, interpret, and synthesize complex clinical and non-clinical statistical reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences

+ Ability to contribute to new or revised company SOPs to continually improve internal processes.

+ Ability to multitask while driving towards critical deadlines on all projects.

+ Superior attention to detail. Ability to identify and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy in US English.

+ Superior computer skills. Experienced with MS Office (Word, Excel, PowerPoint, Outlook). Familiar with current electronic authoring, document management and electronic regulatory submission tools and system.

+ Required to travel as needed, though travel is likely infrequent.


\#ACRP


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-03-04 Expires: 2022-06-18

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Manager of Medical Writing

Kelly Services
Malvern, PA 19355

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