Project Manager - Training
Medical Affairs | Waltham, MA | Full Time
Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological cancers. The company is focusing on the development of the lead product candidate melflufen, a novel peptide-drug conjugate that rapidly delivers a cytotoxic payload into tumor cells. Melflufen is in development as a new treatment for the hematological cancer multiple myeloma and is currently being tested in multiple clinical studies including the pivotal phase 2 HORIZON study and the ongoing phase 3 OCEAN study. Oncopeptides’ US headquarters is based in Waltham, MA with an office in Los Altos, CA, and global headquarters is in Stockholm, Sweden. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO.
The company is in a strong financial position and has an effective Executive Team and Board of Directors. Discover more about Oncopeptides at www.oncopeptides.com
The Project Manager - Training contributes to the performance of the Global Medical Affairs training function by efficient administration, coordination and project assistance including management of applicable systems and processes.
The PM is responsible to coordinate and support the planning, management and delivery of medical training within the scope of medical affairs under the direction of the Director of Medical Affairs Training. This responsibility includes the scheduling of training, coordination of trainings in Veeva Vault MedComms and Quality Docs, management of documentation for training, content uploads as required and in line with rules, regulations and applicable Oncopeptides standard operating procedures.
The PM needs to have a proven ability with efficiency planning, organizing and coordinating work. Furthermore proven track record of collaboration with multiple stakeholders across functions and a close partnership with key stakeholders within Medical Affairs. The PM should at all occasions act to ensure we deliver our medical affairs projects with excellence always having science and patients in focus.
The PM reports into the Medical Excellence Director and must not have commercial objectives or measures and must comply with all applicable rules, regulations and standards. The PM and its management may communicate strategic objectives and Key Performance Indicators (KPIs) to commercial stakeholders to ensure alignment.
This position is based in Waltham, MA.
Essential Duties & Responsibilities:
- The PM is responsible for coordination of Medical Affairs activities and Medical Affairs led trainings, including management of trainings in Veeva Vault MedComms and Quality Docs.
- The PM assists project management of Medical Affairs Training projects and activities
- The PM supports with administration of Medical Affairs trainings projects and activities as well as management of applicable systems and processes (i.e. Veeva Vault all systems with focus on Quality Docs).
- The PM is a super-user of applicable systems and supports others to manage systems with efficiency
- The PM prepares, reviews, collects and archives documents for all applicable Medical training
- projects and activities according to standard operating procedures. This includes documentation for trainings completed as required under the direction of the Director of Medical Affair Training.
- The PM has the operational responsibility to set up project plans including tracking, maintenance and close out activities for medical training
- The PM interacts and partners with external (i.e. contractors/vendors, etc.) and internal stakeholders relevant to the projects and activities under the direction of the Medical Affairs Training Director
- The PM sets up ways of working utilizing digital tools to ensure organizational effectiveness
- The PM supports practical arrangements and contributes to the preparation of internal trainings meetings for medical affairs as required.
- The PM assists in preparation and archiving of financial agreements as well assists other financial processes as per defined functional responsibility
- The PM drives continuous improvement in all applicable medical training project groups to ensure organizational effectiveness through learning
- The PM Assures tasks are of correct quality and in accordance with written procedures and current legal requirements and internal standards
- The PM works in close collaboration with the MRC coordinator for medical trainings
Experience, Education, Training, Traits:
- +3 years of experience administrative and coordinator skills within Medical Affairs
- Proven project-management skills
- Good communication skills
- Pro-active mindset with respect to engaging key stakeholders; Cross functional Stakeholder MA experience (i.e. scientific communications, training, global, etc.)
- Experience in using different systems and tools that support medical activities including evidence generation
- Computer software use proficiency
- Goal oriented with the ability to act independent
- Innovative mindset and competence in agile working
- Ability for life-long learning
- Strong interpersonal and communications skills
- Understanding of medical compliance framework, rules and regulations
- High ethical standards that ensures compliant behaviors line with applicable rules and regulations and standard operating procedures
- Experience with Veeva Vault systems is preferred
- Proficient in Microsoft Office (Excel, Word, Powerpoint, teams, etc.)
- Demonstrated analytical and problem-solving skills; ability to analyze and interpret information and identify/resolve issues
- Ability to critical evaluate and assess tasks/submissions
Driven by the Oncopeptides Values
- Science driven
- Patient focused