Senior Development Operations Lead
Description
Position Overview:
The Senior Development Operations Lead will be responsible across Regulatory, Quality, PV and Medical Affairs functions for specific operational deliverables.
Key Responsibilities:
- Quality/PV: Manage QMS system including transition to and maintenance of new QMS system. Accountable for other areas as needed such as product complaint management and QC of MedWatch forms and PADERS.
- Medical Affairs: Supports key operational aspects such as MSL metrics, training needs, Medical Information support including vendor interface.
- Scientific Support: Supports literature searches and requests for clinical/scientific data related to current and pipeline products and provides education to internal stakeholders as requested.
Specific Responsibilities:
Responsibilities include, but not limited to:
- Manage transition to new QMS system including collaboration with IT, cross-functional coordination of training needs and contractor and vendor management.
- Maintain QMS support after transition to ensure trainings are assigned appropriately based on function and role, track and ensure training is completed on time.
- Medical Affairs support consisting of:
- Support execution of medical plans, including publication strategies, conference planning, thought leader identification/tiering/mapping and engagement.
- Support managing, tracking and reporting monthly MSL metrics.
- Provide congress support / staffing of medical booths.
- Support sales training, MSL training and generation of training materials as needed.
- Provide publication and IIT support.
- Medical Information support including literature searches and as point of contact to the Medical Information vendor.
- Provide pharmacovigilance support including QC review of MedWatch forms and PADERs; as well as follow up with PV vendor to reconcile any identified gaps.
Key Competencies/Requirements:
- Accountability: Assumes responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others.
- Agility: Responds positively to change, embracing and using new practices or values to accomplish goals and solve problems.
- Creativity: Explores and advances opportunities to develop novel solutions and approaches to the improvement of processes and services.
- Empowerment: Finds opportunities to improve and extend their contribution to the organization and their teammates.
- Integrity: Demonstrates the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas.
- Passion: Evidences passion for the organization, our people, and the difference we make daily in improving the lives and health of people.
- Attention to Detail: Ensures information is complete and accurate; follows up with others to ensure that agreements and commitments have been fulfilled.
- Communication: Delivers clear, effective communication and takes responsibility for understanding others.
- Interpersonal: Develops and maintains effective relationships with others; relates well to people from varied backgrounds and in different situations; shows understanding, courtesy, tact, empathy, concern, and politeness.
Preferred Qualifications:
- Life Sciences degree, preferably PharmD, PhD or MD with minimum of 7-9 years of pharmaceutical industry experience required.
- Experience working cross-functionally and leading initiatives that require collaborative skills.
- Excellent written and verbal communication, strong understanding of regulatory and compliance requirements.
- Prior pharmaceutical experience in Medical Affairs including supporting sales and marketing teams on branded products.
- Proficient with Microsoft Office Suite (Word, PowerPoint, and Excel).
- Must be a fast learner, willing to take initiative and to drive results.
Physical Requirements:
- Frequent talking, hearing, visual acuity (detail/accuracy), and repetitive motion
General Statement
Mayne Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
Any communication you receive from Mayne Pharma will never come from a personal email domain or chat service such as "gmail" or "Google Chat". All official communication from Mayne Pharma will be received from our company email domain - @maynepharma.com.