Director, Medical and Scientific Communications

PharmaEssentia U.•Burlington, MA

1d•$235,000 - $260,000•Hybrid

About The Position

The Company: It’s not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You’ll find that rare opportunity at PharmaEssentia. Join us, and let’s transform lives, together. PharmaEssentia Corporation (PEC) is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung. Position Overview: The Director, Medical and Scientific Communications (MSC) is a high visibility role within PharmaEssentia collaborating with key internal and external stakeholders to generate high quality and scientifically rigorous medical information, communication resources and peer-reviewed publications. This key member of the Medical Affairs team will provide communications for our approved product in polycythemia vera (PV) as well as our investigational pipeline products. This position is hybrid in the Burlington, MA office.

Requirements

Attention to detail and the ability to juggle multiple projects, some with tight deadlines
Ability to manage external vendors for completion of medical information, scientific communications and publications.
Knowledge of the operation of Medical Information Call Centers
Ability to create and manage the creation of high-quality documents that effectively and clearly convey scientific data, properly identify/target the audience for each document, and communicate clearly and concisely
Experience in strategic publication planning and execution of publication plans.
Knowledge of current good publication practices and guidelines and medical writing guidelines (e.g., GPP3, ICMJE, CONSORT).
Demonstrated experience interacting with and collaborating with external experts; ability to effectively interact with internal and external stakeholders.
Experience managing external agencies.
Excellent oral communication and interpersonal skills and written communication skills.
Understand clinical trial research, the drug development process, and GCP requirements, and have experience with reviewing clinical trial data.
Proficiency with computer programs such as MS Word, Excel, and PowerPoint, as well as databases such as PubMed.
Manage direct reports.
Travel up to 20%.
Advanced scientific degree, MD strongly preferred
Minimum of 3 years of experience in pharmaceutical medical communications/ publications, or at a medical communications agency in a medical director role.
Clinical research and patient outcomes research experience with publications

Nice To Haves

Prior medical writing experience preferred.
Experience within the pharmaceutical industry is preferred.
Experience in hematology and oncology preferred

Responsibilities

Development of publication projects (abstracts, meeting presentation and manuscripts) in collaboration with internal and external authors.
Creation, revision and approval of medical content for medical information including standard response letters for medical information requests, medical resources on our corporate website, booths at key medical congresses.
Oversight of the Medical Information Call Center
Creation, revision and approval of medical content to support field Medical Science Liaison (MSL) team.
Responsible for the development of abstracts, posters, oral presentations, and manuscripts from PEC-sponsored clinical trials and other PEC-sponsored research, through management of vendors.
Develop and maintain content (e.g., slide decks) for field Medical Science Liaison (MSL) teams for assigned product(s), through management of vendors and/or direct content creation.
Lead projects through the medical content approval process.
Develop and maintain medical information resources including standard response letters for medical information requests, medical resources on our corporate website etc, through management of vendors and/or direct content creation.
Lead projects through the medical content approval process.
Represent PEC as medical information lead at medical information congress booths.
Oversee our Medical Information Call Center vendor (reconcile activities and approve invoices)
In collaboration with key stakeholders within Medical Affairs, lead the medical communications activities at key medical congresses, including the development of medical and/or therapeutic area booth panels, other booth materials, meeting summaries to internal audiences, and post-meeting slide reviews to internal audiences through agency management and direct content development; ensure all materials undergo the appropriate medical content approval process.
Collaborate with biostatistics and other clinical stakeholders to provide direction for analysis plans for the development of post-hoc analyses utilized in publications and other medical content creation.
Collaborate with clinical lead(s) for assigned products for the development and implementation of a comprehensive publication plan.
Build effective partnerships with all internal stakeholders, US and global for successful execution of activities, including publication planning.
Establish strong working relationships with authors and other external experts.
Manage day-to-day interactions with publication agencies and participate in vendor selection activities.
Assist medical communications leads in the management of all financial and contractual aspects of assigned projects, including external vendors.
Coordinate publication reviews and integration of reviewer comments of assigned publication projects.
Ensure that all developed materials are reviewed and appropriately signed off according to PEC Policies and standard operating procedures (SOPs) and maintain archive of approved materials within the appropriate management system.
Assist in the review of assigned publications for medical accuracy, fair balance, and ensuring adherence to PEC policies and good publication practice.
Ensure all assigned PEC-sponsored publications are developed according to PEC publication policy and good publication practice, including published guidelines (e.g., GPP3, ICMJE, CONSORT).
Support development of scientific communications plans and oversee execution of tactics both internally and externally.
Develop and expand scientific proficiency in assigned therapeutic area(s).
Prepare, analyze, interpret, and summarize data.
Evaluate study data from tables and listings.
Participates in department initiatives/projects