Milestonepharma
Senior Manager, Scientific Communications
Milestonepharma, Southern Md Facility, Maryland, us, 20697
WHY JOIN MILESTONE
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At Milestone, we aspire to advance and implement paradigm shifts for cardiac therapy. We are currently focused on developing anti‐arrhythmia treatments for self‐administration outside of the emergency department or hospital setting for patients with acute episodes of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation (AFib), as well as other episodic cardiovascular conditions.In addition to our science and innovation, we are a team guided and driven by our core values. Patient needs and empowerment are continually upheld as central to our mission. Our teamwork is strengthened in an environment where we support and challenge each other while enjoying and celebrating our achievements. We maintain an entrepreneurial, proactive, and action‐oriented mindset that values grit, courage, and resolve highly.Decision‐making is based on evaluating information and an idea’s merits; data‐driven proposals are supported and sought. We act individually and as a team with humility, candor, empathy, and unwavering integrity.We have successfully attracted and empowered best‐in‐class talent, and we seek those with passion to join on our journey to develop treatments and motivate change. We are excited about the possibilities of this team and what we can accomplish together.
YOU WILL BE RESPONSIBLE FOR
Manage and liaise between clinical development/biostatistics and Scientific Communication in order to obtain and confirm accurate data availability for publicationManage the timely and successful development, submission, and execution of publications that support Milestone publication plan objectivesAssist in the management of medical information systems, and the development and renewal of standard response documents (SRDs), FAQs, and custom responses to inquiriesContribute to the development of tactics in the scientific communications and publications planAccurately forecast and manage publication development and submission timelines and work collaboratively to execute in a timely mannerSupport publication planning and design efforts, including partner identification, selection, and onboarding, as well as utilization and upkeep of the publications databaseManage the day-to-day execution of a portfolio of publications that aligns with the publication plan objectives, including holding regular status update meetings with internal teams and external partners/vendorsOversee all publication submission activities with scientific and medical journals to ensure accurate and timely submission adhering to submission-related deliverables and requirementsRemain current with and adherent to all publication development requirements, timelines/milestones, tools, and deliverablesProactively communicate key new information that impacts publications, setbacks, or delays to all relevant parties in a timely manner with a summary of the issue and potential solutionsCoordinate activities with appropriate cross functional partners and external stakeholdersAct as the day-to-day point of contact for publication activitiesProvide regular status updates on publication-related activitiesEnsure that publications and other documents comply with internal policies, procedures, and regulations including confirmation of approval within Milestone’s medical, legal (if necessary) and regulatory reviewEnsure that the publication development process and all materials produced comply with current relevant guidelines, including but not limited to the ICMJE, PhRMA, and GPP4Actively participate as a member of the extended Medical Affairs Team Reviews and interprets product data from preclinical, clinical development, statistics and health economics departments within Milestone and external investigators to determine appropriate publications for inclusion in tactical publications plansProvide updates to all internal stakeholders on publication-related activities in support of company’s productsAssist in the management of the company publication plans and in the development of manuscripts, abstracts, and tactics related to scientific communicationAssist in scientific congress activities and various other medical affairs activitiesProvide support across cross-functional projects including other areas of medical affairs and launch support, clinical development, and regulatory activitiesREQUIREMENTS
Advanced scientific degree (PhD, PharmD, MD, NP/PA)Minimum of 3 years of experience in pharmaceutical medical communications / publications, medical writing, or other medical affairs scientific functions, or at a medical communications agency as a medical director and/or writer. Publications leader experience within the pharmaceutical industry is preferred.Prior Cardiovascular experience preferred.Prior skills and experience with publication databases (i.e., iEnvision) preferred.Experience and knowledge in the following areas are important: successful track record of implementation of medical communication programs; extensive working knowledge of publication best practices; knowledge and understanding of the pharmaceutical commercialization process and medical affairs; working knowledge of the marketing and sales process, particularly marketing strategy, marketing communications, and product promotion; management of consultants and vendors.Extensive experience in strategic publication planning and execution of publication plans.Strong Knowledge of current good publication practices and guidelines and medical writing guidelines (e.g., GPP4, ICMJE, CONSORT).Demonstrated experience interacting with and collaborating with authors and other external experts; ability to effectively interact with internal and external stakeholders.Experience managing external agencies preferred.Understand clinical trial research, the drug development process, and GCP requirements, and have experience with reviewing clinical trial data.Prior medical writing experience preferred.Proficiency with computer programs such as MS Word, Excel, and PowerPoint.Constantly operating a computer, printer, telephone, and other similar office machinery.Responsibilities may periodically require a work schedule that may include working outside of normal work hours, including evenings and weekends, in order to meet business demands.Occasional public contact requiring appropriate business apparel.Embodies a can-do entrepreneurial mindset with a willingness to both lead and support key company initiatives.Leads by example, attracts, and develops talent, builds partnerships, and creates a culture of collaboration and high performing teams that fosters open communication, constructive feedback, and organizational flexibility.Builds strong relationships with peers and cross-functionally with partners outside of team and/or organization to enable higher performance.Combines a welcoming and caring personality with a positive, enthusiastic attitude.Demonstrates high ethical standards and integrity, including demonstrated adherence to all corporate, compliance, and regulatory guidelines and procedures.Learns quickly and adapts rapidly in complex and/or stressful situations, with ability to manage multiple and shifting priorities.Raises the bar and is never satisfied with the status quo by asking questions and challenging appropriately.Creates a learning environment and is open to suggestions and experimentation for improvement.Embraces the ideas of others, nurtures innovation, and manages innovation to reality.Ability to travel (20-30%)COVID-19 VACCINATION POLICY:
All Milestone employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.EEOC STATEMENT:
Milestone believes in a diverse environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Milestone will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
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You could be just the right applicant for this job Read all associated information and make sure to apply.
At Milestone, we aspire to advance and implement paradigm shifts for cardiac therapy. We are currently focused on developing anti‐arrhythmia treatments for self‐administration outside of the emergency department or hospital setting for patients with acute episodes of paroxysmal supraventricular tachycardia (PSVT) and atrial fibrillation (AFib), as well as other episodic cardiovascular conditions.In addition to our science and innovation, we are a team guided and driven by our core values. Patient needs and empowerment are continually upheld as central to our mission. Our teamwork is strengthened in an environment where we support and challenge each other while enjoying and celebrating our achievements. We maintain an entrepreneurial, proactive, and action‐oriented mindset that values grit, courage, and resolve highly.Decision‐making is based on evaluating information and an idea’s merits; data‐driven proposals are supported and sought. We act individually and as a team with humility, candor, empathy, and unwavering integrity.We have successfully attracted and empowered best‐in‐class talent, and we seek those with passion to join on our journey to develop treatments and motivate change. We are excited about the possibilities of this team and what we can accomplish together.
YOU WILL BE RESPONSIBLE FOR
Manage and liaise between clinical development/biostatistics and Scientific Communication in order to obtain and confirm accurate data availability for publicationManage the timely and successful development, submission, and execution of publications that support Milestone publication plan objectivesAssist in the management of medical information systems, and the development and renewal of standard response documents (SRDs), FAQs, and custom responses to inquiriesContribute to the development of tactics in the scientific communications and publications planAccurately forecast and manage publication development and submission timelines and work collaboratively to execute in a timely mannerSupport publication planning and design efforts, including partner identification, selection, and onboarding, as well as utilization and upkeep of the publications databaseManage the day-to-day execution of a portfolio of publications that aligns with the publication plan objectives, including holding regular status update meetings with internal teams and external partners/vendorsOversee all publication submission activities with scientific and medical journals to ensure accurate and timely submission adhering to submission-related deliverables and requirementsRemain current with and adherent to all publication development requirements, timelines/milestones, tools, and deliverablesProactively communicate key new information that impacts publications, setbacks, or delays to all relevant parties in a timely manner with a summary of the issue and potential solutionsCoordinate activities with appropriate cross functional partners and external stakeholdersAct as the day-to-day point of contact for publication activitiesProvide regular status updates on publication-related activitiesEnsure that publications and other documents comply with internal policies, procedures, and regulations including confirmation of approval within Milestone’s medical, legal (if necessary) and regulatory reviewEnsure that the publication development process and all materials produced comply with current relevant guidelines, including but not limited to the ICMJE, PhRMA, and GPP4Actively participate as a member of the extended Medical Affairs Team Reviews and interprets product data from preclinical, clinical development, statistics and health economics departments within Milestone and external investigators to determine appropriate publications for inclusion in tactical publications plansProvide updates to all internal stakeholders on publication-related activities in support of company’s productsAssist in the management of the company publication plans and in the development of manuscripts, abstracts, and tactics related to scientific communicationAssist in scientific congress activities and various other medical affairs activitiesProvide support across cross-functional projects including other areas of medical affairs and launch support, clinical development, and regulatory activitiesREQUIREMENTS
Advanced scientific degree (PhD, PharmD, MD, NP/PA)Minimum of 3 years of experience in pharmaceutical medical communications / publications, medical writing, or other medical affairs scientific functions, or at a medical communications agency as a medical director and/or writer. Publications leader experience within the pharmaceutical industry is preferred.Prior Cardiovascular experience preferred.Prior skills and experience with publication databases (i.e., iEnvision) preferred.Experience and knowledge in the following areas are important: successful track record of implementation of medical communication programs; extensive working knowledge of publication best practices; knowledge and understanding of the pharmaceutical commercialization process and medical affairs; working knowledge of the marketing and sales process, particularly marketing strategy, marketing communications, and product promotion; management of consultants and vendors.Extensive experience in strategic publication planning and execution of publication plans.Strong Knowledge of current good publication practices and guidelines and medical writing guidelines (e.g., GPP4, ICMJE, CONSORT).Demonstrated experience interacting with and collaborating with authors and other external experts; ability to effectively interact with internal and external stakeholders.Experience managing external agencies preferred.Understand clinical trial research, the drug development process, and GCP requirements, and have experience with reviewing clinical trial data.Prior medical writing experience preferred.Proficiency with computer programs such as MS Word, Excel, and PowerPoint.Constantly operating a computer, printer, telephone, and other similar office machinery.Responsibilities may periodically require a work schedule that may include working outside of normal work hours, including evenings and weekends, in order to meet business demands.Occasional public contact requiring appropriate business apparel.Embodies a can-do entrepreneurial mindset with a willingness to both lead and support key company initiatives.Leads by example, attracts, and develops talent, builds partnerships, and creates a culture of collaboration and high performing teams that fosters open communication, constructive feedback, and organizational flexibility.Builds strong relationships with peers and cross-functionally with partners outside of team and/or organization to enable higher performance.Combines a welcoming and caring personality with a positive, enthusiastic attitude.Demonstrates high ethical standards and integrity, including demonstrated adherence to all corporate, compliance, and regulatory guidelines and procedures.Learns quickly and adapts rapidly in complex and/or stressful situations, with ability to manage multiple and shifting priorities.Raises the bar and is never satisfied with the status quo by asking questions and challenging appropriately.Creates a learning environment and is open to suggestions and experimentation for improvement.Embraces the ideas of others, nurtures innovation, and manages innovation to reality.Ability to travel (20-30%)COVID-19 VACCINATION POLICY:
All Milestone employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.EEOC STATEMENT:
Milestone believes in a diverse environment and is committed to equal employment opportunities for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Milestone will make reasonable accommodations for qualified individuals with known disabilities in accordance with applicable law.
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