Manager, Medical Information

Dicerna Pharmaceuticals, Inc. Lexington , MA 02421

Posted 1 month ago

The Manager, Medical Information-Medical Affairs will assist with the analysis and creation of key, medical affairs deliverables, including creation of: abstracts/posters/manuscripts, resources for the field Medical Affairs team (slide decks and training materials), and creation of disease-state educational materials. This individual will work closely with clinical development colleagues regarding timing of data output from studies. This individual should be able to critically analyze data and then translate data into formats that meet the scientific needs of the external HCP community. This individual will provide input into the review and approval of scientific materials in development within medical affairs and will assist with the scientific review of various R & D-related documents, including protocols and study reports for clinical trials.

Key Responsibilities

  • Oversee development of as well as plan, write, edit and format various scientific pieces and deliverables for the medical affairs team, including: slides decks, abstracts/posters/manuscripts and disease educational materials.

  • Ensure highest degree of quality and medical accuracy for all pieces developed within medical affairs alongside achieving timely delivery.

  • Review and approval of scientific materials developed, including "fact-checking" prn.

  • Review of scientific documents, including protocols and study reports.

  • Collaborate internally and externally as well as with the Global Team.

Qualifications

  • Advanced clinical or scientific degree (PharmD, PhD, NP/PA or MD/DO) required.

  • Minimum of 8 years of experience in the pharmaceutical, biotech or related industry, with at least 5 years of experience in medical writing or publications.

  • Experience in renal disease and/or is nice to have.

  • Experience managing contract medical writers a plus.

  • Proficiency in Microsoft Windows, Word, Excel, and PowerPoint required.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Medical Director Neuroscience

Takeda Pharmaceutical Company Ltd

Posted 4 days ago

VIEW JOBS 4/3/2020 12:00:00 AM 2020-07-02T00:00 By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that I agree with Takeda's Privacy Notice, Privacy Policy and Terms of Use. Job Description Takeda Pharmaceuticals Job Description Job Title: Senior Medical Director, US Medical Function: US Medical Office Department: US Medical Office (USMO), Therapeutic Area Reports To (Title): Vice President, US Medical Written By: Kirk Shepard/Charles Baum/Lou Mini/Karen Lasch Date Written August 2013, Revised March 2019 Job Number 60040295 OBJECTIVE: (Briefly summarize the overall purpose of the position. Objectives should be written in 3 - 4 statements). Provides strategic planning, scientific and medical support and is responsible for overseeing the development and implementation of medical and scientific communication platform, research strategies including post-approval investigator initiated research, phase 4 and contracted research. In addition, provides medical input into the long-term vision and growth strategies for the compounds within the related portfolio of TPUSA. ACCOUNTABILITIES: (Describe the primary duties and responsibilities of the job. Approximately 5 - 10 task statements should be identified). * Serve as the in-house medical and scientific expert for drugs within assigned therapeutic area and represent medical affairs on the following committees: Functional and Commercial Planning Teams strategic Global Program Teams (GPTs), Medical-Regulatory-Legal (MRL) Teams, Investigator Initiated Sponsored Research (IISR) and Medical Affairs research Committees, Medical Education Committees, , Publication teams, and other teams as designated. * Interact internally with and support colleagues from Alliance Management, Business Development, Government Affairs, Marketing and Sales. * Develop and maintain relationships with key external experts through Professional Associations, Professional Meetings and Conferences, etc. in support of common scientific objectives. * Seek input and alignment with key internal stakeholders on therapeutic area initiatives (e.g, research gap analysis, communication plans, novel indications, etc.) * Assist in managing the budget for the specific Cost Center and provide direction and oversight for the US MA overall therapeutic area budget. * Provide medical and scientific direction and review for pre and post launch regulatory strategies (which may include label (PI), protocols, NDAs and Supplemental NDA's, etc) * Either directly, or indirectly through supervision, oversee the medical review and sign off of promotional pieces in support of the Medical-Regulatory-Legal committee for products within your therapeutic area(s). * Participate in the publications strategy for assigned compounds by providing scientific and publication planning input, including review and sign off of materials for medical/scientific presentations and publications. * Interact internally with senior level management requiring negotiation to guide the overall activities of the specific compound and therapeutic area. * Develop and maintain relationships externally through Advisory Boards, Professional Associations and Meetings to achieve Takeda's scientific objectives. * Participate in external alliances and partnerships in order to further Takeda's scientific objectives. * Provide support for departmental initiatives and other duties as assigned. SCOPE OF SUPERVISION: NUMBER OF EMPLOYEES SUPERVISED Direct In-Direct Managers/Supervisors/Directors 1-3 0 Exempt/Professional/Technical 0-2 0 Non-Exempt 0 1 EDUCATION, EXPERIENCE AND SKILLS: (List the education and experience required to perform the primary responsibilities of the job. Equivalent combinations of education and experience should be noted). Required: * MD degree or DO degree preferred with at least 7 plus years of experience in pharmaceutical industry and/or academic research, relevant clincal experience, or equivalent combination * Other advanced degreed professionals (PharmD, Ph. D) considered depending on past relevant pharmaceutical industry experience, and/or clinical work, research, or academic endeavors * Experience with publication activities, congress presentations and public speaking Desired: * Life cycle management experience * Prior experience in Medical Affairs * Board certification in therapeutic are related to position LICENSES/CERTIFICATIONS: Maintain minimum standards of education/certification in individual professional discipline PHYSICAL DEMANDS: (Identify any physical demands required in the performance of the primary responsibilities of the position). The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Ability to drive to or fly to various meetings/client sites - limited overnight. Some international travel may be required * Manual dexterity required to operate office equipment (i.e. computers, phones, etc.) The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Due to travel, the work environment includes exposure to both inside and outside working conditions. Temperature and length of exposure varies depending upon meeting location and transportation. TRAVEL REQUIREMENTS: See above ADDITIONAL INFORMATION: Knowledge * Industry Knowledge - understands the pharmaceutical industry regulations governing medical functions within industry activities and medical regulatory process * Product Knowledge -understands medical/therapeutic impact of products; understanding of potential product applications * Takeda Operations - understands Takeda's operating structure and methods including a thorough knowledge of the foreign-owned parent company Skills * Leadership - ability to provide ongoing feedback and coaching to employees and guides leaders within the department in doing the same * Leadership - ability to use confidence, decisiveness and a willingness to listen to influence and engage others in the accomplishment of functional goals * Budget Management - ability to develop an operating budget to monitor and control expenditures; manages variances between budgeted and actual expenditures of time, dollars, and personnel * Communication - ability to communicate ideas and data both verbally and written in a persuasive and appropriate manner * Analytical Skills - ability to analyze a wide variety of scientific data including financial figures and market research data to make management decisions * Business Process Acumen - ability to apply the knowledge of Takeda's core business capabilities to help the organization meet its goals and desired outcomes * Strategic Approach - ability to predict broad-based changes in business partner environment and translates them into functional strategies to continually meet business partner needs * Knowledge Sharing - ability to capture knowledge within the organization; improves solutions, processes, and deliverables through use of information; improves information capital by contributing experience, theories, deliverables and models for others to use * Knowledge Management - ability to document resolution to issues and or customer concerns in a manner that ensures reusability of that resolution * Pharmaceutical Industry Acumen -ability to develop and implement business solutions based on trends, opportunities, needs, and market direction within the pharmaceutical industry Locations Lexington, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Takeda Pharmaceutical Company Ltd Lexington MA

Manager, Medical Information

Dicerna Pharmaceuticals, Inc.